Blincyto

(Blinatumomab)

ApprovedMonoclonal antibody

Blinatumomab is used to treat certain types of blood cancer, specifically a form of leukemia where cancer cells are found in the blood and bone marrow. It works by helping the body's immune system recognize and destroy these cancer cells.[2] Blincyto is currently approved and in use across 25 indications[4].[1]

Blincyto is one of 363 biologic programs targeting Systemic Lupus Erythematosus. It is currently in Approved.

Indications

140

Total Trials

Active Trials

362

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Systemic Lupus ErythematosusRecruiting

Down SyndromeRecruiting

LeukemiaRecruiting

Lymphoid LeukemiaUnknown

Acute Lymphoblastic LeukemiaTerminated

MemoryActive, not recruiting

Myasthenia GravisNot yet recruiting

ChemotherapyRecruiting

Acute Lymphoblastic Leukemia (ALL)Active, not recruiting

Ph+ ALLRecruiting

Systemic Lupus ErythematosusPhase 2

Recruiting

Down SyndromePhase 2

Recruiting

LeukemiaApproved

Recruiting

Lymphoid LeukemiaPreclinical

Unknown

Acute Lymphoblastic LeukemiaApproved

Terminated

MemoryPhase 2

Active, not recruiting

Myasthenia GravisPhase 3

Not yet recruiting

ChemotherapyPhase 2

Recruiting

Acute Lymphoblastic Leukemia (ALL)Phase 3

Active, not recruiting

Ph+ ALLPreclinical

Recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

228 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Blincyto

Amgen

Approved

1 2

Busulfex

Akero Therapeutics

Phase 3

3 3

BESREMI

PPharmaEssentia

Phase 3

2 4

Glypressin

MMallinckrodt

Phase 3

1 5

Giapreza

LLa Jolla Pharmaceutical Company

Phase 3

1 6

DWP16001

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 7

Mecobalamin

Eisai

Phase 3

1 8

Tegoprazan

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Phase 3

4 9

Avalglucosidase Alfa

Sanofi

Phase 3

1 10

Hemay005

GGanzhou Hemay Pharmaceutical Co., Ltd

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Acute Lymphoblastic Leukemia

NCT04872790

Phase 2Active, not recruiting

Acute Lymphoblastic Leukemia

NCT03541083

PreclinicalActive, not recruiting

Acute Lymphoblastic Leukemia

NCT03114865

Phase 2Recruiting

Blinatumomab

NCT06250959

Q1 2027

Phase 2Recruiting

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

NCT03739814

PreclinicalActive, not recruiting

Refractory Acute Lymphoblastic Leukemia

NCT05192889

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia43 trials

Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia

Completed·GGoethe University·Phase 2·NCT03109093·83 enrolled

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

Completed· Amgen logo

Amgen·Phase 2·NCT01207388·116 enrolled

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

Show 40 more trials

D-ALBA Frontline Sequential Dasatinib and Blinatumomab in Adult Philadelphia Positive Acute Lymphoblastic Leukemia

Unknown status·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT02744768·60 enrolled

Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL

Withdrawn·—·Phase 2·NCT04448834

Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04329325·17 enrolled

Phase II Study of the BiTE® Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

Completed· Amgen logo

Amgen·Phase 2·NCT00560794·21 enrolled

Blinatumomab in High-risk B-cell Precursor Acute Lymphoblastic Leukemia

Active, not recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT03709719·95 enrolled

Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT04872790·20 enrolled

Ibrutinib and Blinatumomab in Treating Patients With Relapsed or Refractory B Acute Lymphoblastic Leukemia

Recruiting·BBrian Jonas·Phase 2·NCT02997761·20 enrolled

Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL)

Completed·IInstitute of Hematology and Blood Transfusion, Czech Republic·Phase 2·NCT04554485·27 enrolled

Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot

Unknown status·FFederal Research Institute of Pediatric Hematology, Oncology and Immunology·N/A·NCT04723342·180 enrolled

Study to Investigate Intravenous Blinatumomab in Japanese Adult Participants With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL)

Completed· Amgen logo

Amgen·Phase 1·NCT06649006·6 enrolled

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia

Completed· Amgen logo

Amgen·Phase 2·NCT02000427·45 enrolled

Blinatumomab Maintenance Following Allogeneic Hematopoietic Cell Transplantation for Patients With Acute Lymphoblastic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02807883·23 enrolled

Efficacy and Safety of the BiTE Antibody Blinatumomab in Chinese Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Completed· Amgen logo

Amgen·Phase 3·NCT03476239·121 enrolled

Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03263572·90 enrolled

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Recruiting·MMartin Schrappe·Phase 3·NCT03643276·5,000 enrolled

Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Withdrawn· Novartis logo

Novartis·Phase 3·NCT03628053

Blinatumomab Versus Standard of Care Chemotherapy in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

Terminated· Amgen logo

Amgen·Phase 3·NCT02013167·405 enrolled

Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06658938·30 enrolled

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

Terminated· Amgen logo

Amgen·Phase 4·NCT04506086·10 enrolled

Venetoclax in Addition to Blinatumomab in Adult Patients With Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia (BCP-ALL)

Active, not recruiting·GGoethe University·Phase 1/2·NCT05182385·30 enrolled

Clinical Study With Blinatumomab in Pediatric and Adolescent Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Completed· Amgen logo

Amgen·Phase 1/2·NCT01471782·93 enrolled

Pembrolizumab and Blinatumomab in Treating Participants With Recurrent or Refractory Acute Lymphoblastic Leukemia

Active, not recruiting·—·Phase 1/2·NCT03512405·36 enrolled

Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03518112·6 enrolled

Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02877303·80 enrolled

TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II

Recruiting·TTanja Andrea Gruber·Phase 1/2·NCT05848687·90 enrolled

Study of Blinatumomab in Japanese Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Completed· Amgen logo

Amgen·Phase 1/2·NCT02412306·66 enrolled

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL)

Completed· Amgen logo

Amgen·Phase 2·NCT01466179·225 enrolled

Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)

Completed· Amgen logo

Amgen·Phase 2·NCT01209286·36 enrolled

Blinatumomab Added to Prephase and Consolidation Therapy in Precursor B-acute Lymphoblastic Leukemia in Adults.

Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 2·NCT03541083·71 enrolled

An Open-label, Multicenter, Phase 2 Study to Evaluate Efficacy, Safety, and Pharmacokinetics (PK) of Blinatumomab in Chinese Pediatric Subjects With Relapsed or Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT06054113·18 enrolled

A Phase IB/II Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Preclinical·NCT03114865·44 enrolled

Interfant-21 International Collaborative Treatment Protocol for Infants Under One Year With KMT2A-rearranged Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia.

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 3·NCT05327894·160 enrolled

Open-label, Phase I/II Study to Evaluate Safety and Efficacy of Asciminib With Chemotherapy Followed by Asciminib Plus Blinatumomab in Pediatric, Adolescent, and Young Adults With Relapsed or Refractory BCR::ABL1-positive (Philadelphia Positive, Ph+) or BCR::ABL1-like (Ph-like) ALL

Recruiting· Novartis logo

Novartis·Preclinical·NCT07387926·50 enrolled

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Recruiting·NNorthside Hospital, Inc.·Phase 2·NCT05519579·20 enrolled

A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Active, not recruiting· Amgen logo

Amgen·Preclinical·NCT07134088·104 enrolled

A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02003222·488 enrolled

Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT07227584·67 enrolled

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06287229·40 enrolled

A Phase 2 Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients >/= 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone and Blinatumomab for Patients >/= 65 Years of Age With Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, Relapsed/Refractory Ph+ ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) With Known or Presumed Activating Dasatinib-Sensitive Mutations or Kinase Fusions (DSMKF)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02143414·53 enrolled

SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT06533748·128 enrolled

Blinatumomab17 trials

Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

Recruiting·SSichuan University·Phase 2·NCT06111625·20 enrolled

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Recruiting·MMedical College of Wisconsin·Phase 2·NCT04746209·25 enrolled

RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

Recruiting·CChen Suning·Phase 2·NCT06250959·124 enrolled

Show 14 more trials

Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL

Completed· Amgen logo

Amgen·Phase 1·NCT00274742·76 enrolled

Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

Not yet recruiting·SSichuan University·Phase 2·NCT06075238·68 enrolled

Blinatumomab Maintenance After Allo-HSCT

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06438796·59 enrolled

Blinatumomab Bridging Therapy for BALL

Terminated·MMichael Burke·Phase 2·NCT04556084·2 enrolled

Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 2·NCT05559450·80 enrolled

NGS MRD-Guided Blinatumomab Treatment for Pediatric B-ALL

Not yet recruiting·TThe Children's Hospital of Zhejiang University School of Medicine·N/A·NCT06763302·1,220 enrolled

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

Recruiting· Amgen logo

Amgen·Phase 1/2·NCT04521231·281 enrolled

ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML

Recruiting·MMarlise Luskin, MD·Phase 1·NCT03595917·40 enrolled

Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 2·NCT06554626·20 enrolled

Pediatric-type Therapy With Pre-transplant Blinatumomab for HR Patients - Phase II Study

Unknown status·IIsraeli Medical Association·Phase 2·NCT04334993·110 enrolled

Immune Reconstitution After Allo-HSCT and Blinatumomab

Unknown status·SSichuan University··NCT06075212·20 enrolled

Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia

Suspended·MM.D. Anderson Cancer Center·Phase 2·NCT07192237·40 enrolled

Phase II Study of the Combination of Subcutaneous Blinatumomab and Olverembatinib in Patients With Philadelphia Chromosome (ph)-Positive and/or BCR::ABL1 Positive Acute Lymphoblastic Leukemia (ALL)

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07178912·60 enrolled

A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07283640·20 enrolled

Diffuse Large B-Cell Lymphoma4 trials

Clinical Study With Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Completed· Amgen logo

Amgen·Phase 2·NCT01741792·25 enrolled

Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)

Terminated· Amgen logo

Amgen·Phase 2·NCT03298412·10 enrolled

Safety and Efficacy of Blinatumomab in Adults With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma

Completed· Amgen logo

Amgen·Phase 2·NCT03023878·47 enrolled

Show 1 more trial

Blinatumomab Consolidation Post Autologous Stem Cell Transplantation in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

Completed·WWashington University School of Medicine·Phase 1·NCT03072771·14 enrolled

Lymphoma4 trials

Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adults With Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)

Completed· Amgen logo

Amgen·Phase 1·NCT03340766·31 enrolled

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02568553·35 enrolled

A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma

Terminated·MMassachusetts General Hospital·Phase 2·NCT02811679·13 enrolled

Show 1 more trial

A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma

Completed· Amgen logo

Amgen·Phase 1·NCT02961881·35 enrolled

B-cell acute lymphoblastic leukemia4 trials

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting· Merck & Co. logo

Merck & Co.·Preclinical·NCT07570173·340 enrolled

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

Recruiting·CCharite University, Berlin, Germany·Phase 3·NCT07476729·750 enrolled

A Phase 1b/2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Combination With Low Intensity Chemotherapy in Older Patients With Newly Diagnosed B-Cell Acute Lymphoblastic Leukemia

Active, not recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07153796·3 enrolled

Show 1 more trial

A Phase 1/2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia

Not yet recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT07313852·26 enrolled

47 more indications

Acute Lymphoblastic Leukemia (ALL)4 trials

Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL

Recruiting·BBambino Gesù Hospital and Research Institute·Preclinical·NCT07297914·1,000 enrolled

TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT03849651·69 enrolled

Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate/High Risk Childhood B-cell ALL

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT06764238·1,800 enrolled

Show 1 more trial

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT04994717·303 enrolled

Leukemia3 trials

Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Recruiting·SSuping ZHANG·Phase 4·NCT06339775·60 enrolled

Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 2/3·NCT06607419·90 enrolled

Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05645718·27 enrolled

Acute Leukemia of Ambiguous Lineage3 trials

Immune-targeted Combination With Chemotherapy for Acute Leukemia of Ambiguous Lineage

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06991920·50 enrolled

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06317662·153 enrolled

A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)

Not yet recruiting·SSWOG Cancer Research Network·Phase 2·NCT07636564·90 enrolled

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL13 trials

A Phase 1 Study of Asciminib-Based Induction Therapy in Newly Diagnosed Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Not yet recruiting·CCity of Hope Medical Center·Phase 1·NCT07914166·21 enrolled

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04530565·348 enrolled

Phase I/II Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT01371630·276 enrolled

B Acute Lymphoblastic Leukemia3 trials

A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT03914625·6,720 enrolled

An International Phase 2 Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06124157·222 enrolled

A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Recruiting·CChildren's Oncology Group·Phase 3·NCT03959085·5,951 enrolled

Recurrent B Acute Lymphoblastic Leukemia3 trials

Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02101853·669 enrolled

A Phase 1/1b Study Evaluating Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) and Venetoclax in Combination With Blinatumomab in Adults With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Recruiting·CCity of Hope Medical Center·Phase 1·NCT07133997·26 enrolled

A Phase 1 Study of Blinatumomab in Combination With Checkpoint Inhibitor(s) of PD-1 (Nivolumab) or Both PD-1 (Nivolumab) and CTLA-4 (Ipilimumab) in Patients With Poor-Risk, Relapsed or Refractory CD19+ Precursor B-Lymphoblastic Leukemia

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT02879695·28 enrolled

Acute Leukemia2 trials

Subcutaneous Blinatumomab for Treatment of Adult Patients With CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

Recruiting·WWest Virginia University·Phase 2·NCT07222579·78 enrolled

Pembro + Blina Combination in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemia or Lymphoma

Withdrawn·—·Phase 1·NCT03605589

Systemic Lupus Erythematosus2 trials

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

Recruiting·MMao Jianhua·Phase 1·NCT06789107·6 enrolled

A Phase 2, Open Label, Multicenter, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

Recruiting· Amgen logo

Amgen·Phase 2·NCT06570798·220 enrolled

Chemotherapy2 trials

Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT

Recruiting·GGoethe University·Phase 2·NCT06061094·220 enrolled

CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL

Recruiting·UUniversity of Chicago·Phase 1/2·NCT07294677·104 enrolled

Relapsed/Refractory2 trials

Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL

Completed·—·Phase 1·NCT03751709·22 enrolled

Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL

No longer available· Amgen logo

Amgen··NCT02187354

Memory2 trials

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT07052370·30 enrolled

Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2·NCT02790515·170 enrolled

Richter Transformation2 trials

BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

Completed·FFrench Innovative Leukemia Organisation·Phase 2·NCT03931642·41 enrolled

Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT03121534·9 enrolled

Myasthenia Gravis2 trials

Blinatumomab in Refractory Myasthenia Gravis (BLINA-MG)

Not yet recruiting·ZZhongming Qiu·Phase 2/3·NCT06684184·10 enrolled

Blinatumomab for Treatment of Refractory Myasthenia Gravis

Not yet recruiting·—·Phase 2/3·NCT06836973·2 enrolled

Leukemia, Acute Lymphoblastic2 trials

ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) With Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)

Recruiting·MMats Heyman·Phase 3·NCT04307576·6,430 enrolled

Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

Completed· Amgen logo

Amgen·Phase 3·NCT02393859·111 enrolled

Newly Diagnosed1 trial

Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study

Not yet recruiting·SShandong University··NCT06649422·36 enrolled

Induction Therapy1 trial

Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL

Completed·CChen Suning·Phase 2·NCT05557110·35 enrolled

Advanced or Metastatic Solid Tumors1 trial

A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

Terminated·IImugene Limited·Phase 1·NCT06063317·25 enrolled

Minimal Residual Disease1 trial

Minimal Residual Disease Quantification by Next-generation Sequencing in Pediatric B-ALL Children Patients Treated With Blinatumomab Consolidation

Unknown status·XXiaojun Xu··NCT05837689·20 enrolled

Refractory1 trial

Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL

Recruiting· Ascentage Pharma Group Inc. logo

Ascentage Pharma Group Inc.·Phase 1·NCT04260022·242 enrolled

Pediatric1 trial

Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2/3·NCT06882057·3,000 enrolled

Stem Cell Transplant1 trial

Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

Terminated·UUniversity of British Columbia·Phase 2·NCT04044560·8 enrolled

Adult1 trial

Study in Adult Ph-positive ALL

Unknown status·—·Phase 2·NCT04688983·180 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Prospective, Single-arm, Multicenter Clinical Study on Haploidentical Hematopoietic Stem Cell Transplantation in Patients With MRD Positive CD19+ALL Treated With Conditioning Regimens Containing Blinatumomab

Unknown status·ZZhejiang University·Phase 1·NCT06125106·31 enrolled

HSCT1 trial

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Terminated·—·Phase 2·NCT04785547·3 enrolled

Relapsed or Refractory1 trial

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

Completed· Amgen logo

Amgen·Phase 1·NCT04524455·17 enrolled

PET1 trial

PETHEMA-BLIN-01/PET069014 (BLIN-01)

Terminated·PPETHEMA Foundation·Phase 2·NCT03523429·11 enrolled

Aggressive B-cell NHL1 trial

Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL

Completed· Amgen logo

Amgen·Phase 2/3·NCT02910063·41 enrolled

Multiple Myeloma1 trial

Pilot Study of Blinatumomab in Combination With Salvage Autologous Stem Cell Transplantation for Patients With Refractory Multiple Myeloma

Terminated·—·Phase 1·NCT03173430·6 enrolled

Older Patients1 trial

Treatment of Older Patients With B-precursor ALL With Sequential Dose Reduced Chemotherapy and Blinatumomab

Completed·GGoethe University·Phase 2·NCT03480438·52 enrolled

Relapsed/Refractory B-cell ALL1 trial

Blinatumomab & Pembrolizumab for Adults With Relapsed/Refractory B-cell ALL With High Marrow Lymphoblasts

Completed·UUniversity of California, San Diego·Phase 1/2·NCT03160079·16 enrolled

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06308588·40 enrolled

Myeloid Leukemia1 trial

Phase I/II of the Combination of Fludarabine, Cytarabine, Idarubicin, G-CSF (FLAG-Ida) With Venetoclax and Asciminib in Patients With Advanced Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Not yet recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07604233·30 enrolled

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative1 trial

A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03739814·84 enrolled

Refractory Acute Lymphoblastic Leukemia1 trial

RAVEN: A Phase I/II Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Preclinical·NCT05192889·35 enrolled

Primary Sjögren's Syndrome (pSS)1 trial

Exploratory Study on the Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Moderate to Severe Primary Sjögren's Syndrome

Not yet recruiting·BBeijing Tongren Hospital·Phase 2·NCT07852234·12 enrolled

Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)1 trial

A Prospective, Umbrella, Phase 2 Study of Immunotargeted Agents Combined With Low-Dose Chemotherapy in Adult Patients With Newly Diagnosed Philadelphia Chromosome-Positive B-Cell Acute Lymphoblastic Leukemia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07840976·22 enrolled

Adult Acute Lymphoblastic Leukemia in Complete Remission1 trial

Phase II Study of Blinatumomab in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02458014·37 enrolled

Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia1 trial

A Phase 3, Open-label, Randomized, Controlled Trial of Subcutaneous Versus Intravenous Blinatumomab in Newly Diagnosed Adults With Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukaemia

Not yet recruiting· Amgen logo

Amgen·Phase 3·NCT07223190·560 enrolled

Acute Lymphoblastic Leukemia, B-precursor1 trial

Short-term Blinatumomab Intensification for MRD-Negative Acute B-Cell Lymphoblastic Leukemia Before Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Randomized Controlled Study

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Preclinical·NCT07003737·114 enrolled

Down syndrome1 trial

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04546399·461 enrolled

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Phase II Study of the Sequential Combination of Low-Intensity Chemotherapy and Ponatinib Followed by Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03147612·22 enrolled

Acute Lymphoblastic Leukemia, Adult1 trial

A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07495631·43 enrolled

Ph+ ALL1 trial

Low-intensity Chemotherapy Combined With Targeted-Immunotherapy for Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Prospective Clinical Cohort Study

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Preclinical·NCT07493161·110 enrolled

Autoimmune Encephalitis (AE)1 trial

Efficacy and Safety of Low-Dose Blinatumomab in the Treatment of Refractory Autoimmune Encephalitis and Autoimmune Cerebellitis

Not yet recruiting·BBeijing Tiantan Hospital·Approved·NCT07686042·12 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 3, 2014

BLINCYTO

NDA BLA125557

Dec 3, 2014

BLINCYTO

BLA BLA125557

Aug 30, 2016

BLINCYTO

NDA BLA125557

Aug 30, 2016

BLINCYTO

NDA BLA125557

May 3, 2017

BLINCYTO

NDA BLA125557

Jul 11, 2017

BLINCYTO

NDA BLA125557

Nov 30, 2017

BLINCYTO

NDA BLA125557

Mar 29, 2018

BLINCYTO

NDA BLA125557

Apr 10, 2018

BLINCYTO

NDA BLA125557

Apr 18, 2019

BLINCYTO

NDA BLA125557

Apr 18, 2019

BLINCYTO

NDA BLA125557

Mar 20, 2020

BLINCYTO

NDA BLA125557

Mar 11, 2021

BLINCYTO

NDA BLA125557

Mar 11, 2021

BLINCYTO

NDA BLA125557

Mar 11, 2021

BLINCYTO

NDA BLA125557

Feb 18, 2022

BLINCYTO

NDA BLA125557

Dec 5, 2022

BLINCYTO

NDA BLA125557

Jun 20, 2023

BLINCYTO

NDA BLA125557

Jun 20, 2023

BLINCYTO

NDA BLA125557

Feb 8, 2024

BLINCYTO

NDA BLA125557

Jun 14, 2024

BLINCYTO

NDA BLA125557

Dec 17, 2024

BLINCYTO

NDA BLA125557

Apr 29, 2025

BLINCYTO

NDA BLA125557

Oct 21, 2025

BLINCYTO

NDA BLA125557

Sources

References

[1]
ClinicalTrials.gov — 140 trial records for Blinatumomab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Blincyto drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Blinatumomab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Blinatumomab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA125557). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD19 Cross-Linking Agent; T Cell Surface Glycoprotein CD3 Cross-Linking Agent[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Amgen

Blincyto

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Acute Lymphoblastic Leukemia43 trials

Blinatumomab17 trials

Diffuse Large B-Cell Lymphoma4 trials

Lymphoma4 trials

B-cell acute lymphoblastic leukemia4 trials

Acute Lymphoblastic Leukemia (ALL)4 trials

Leukemia3 trials

Acute Leukemia of Ambiguous Lineage3 trials

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL13 trials

B Acute Lymphoblastic Leukemia3 trials

Recurrent B Acute Lymphoblastic Leukemia3 trials

Acute Leukemia2 trials

Systemic Lupus Erythematosus2 trials

Chemotherapy2 trials

Relapsed/Refractory2 trials

Memory2 trials

Richter Transformation2 trials

Myasthenia Gravis2 trials

Leukemia, Acute Lymphoblastic2 trials

Newly Diagnosed1 trial

Induction Therapy1 trial

Advanced or Metastatic Solid Tumors1 trial

Minimal Residual Disease1 trial

Refractory1 trial

Pediatric1 trial

Stem Cell Transplant1 trial

Adult1 trial

Hematopoietic Stem Cell Transplantation1 trial

HSCT1 trial

Relapsed or Refractory1 trial

PET1 trial

Aggressive B-cell NHL1 trial

Multiple Myeloma1 trial

Older Patients1 trial

Relapsed/Refractory B-cell ALL1 trial

Efficacy and Safety1 trial

Transplantation1 trial

JAK Inhibitor1 trial

Philadelphia Chromosome-Positive1 trial

Myeloid Leukemia1 trial

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative1 trial

Refractory Acute Lymphoblastic Leukemia1 trial

Primary Sjögren's Syndrome (pSS)1 trial

Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)1 trial

Adult Acute Lymphoblastic Leukemia in Complete Remission1 trial

Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia1 trial

Acute Lymphoblastic Leukemia, B-precursor1 trial

Down syndrome1 trial

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Acute Lymphoblastic Leukemia, Adult1 trial

Ph+ ALL1 trial

Autoimmune Encephalitis (AE)1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News