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 368 biologic programs targeting Blinatumomab. It is currently in Approved.

Indications

136

Total Trials

Active Trials

367

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

BlinatumomabNot yet recruiting

Lymphoid LeukemiaUnknown

Systemic Lupus ErythematosusRecruiting

Leukemia, Acute LymphoblasticCompleted

Acute Lymphoblastic Leukemia (ALL)Active, not recruiting

Autoimmune Encephalitis (AE)Not yet recruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1Active, not recruiting

Ph+ ALLRecruiting

Recurrent B Acute Lymphoblastic LeukemiaActive, not recruiting

Acute Lymphoblastic Leukemia, AdultRecruiting

BlinatumomabPhase 2

Not yet recruiting

Lymphoid LeukemiaPreclinical

Unknown

Systemic Lupus ErythematosusPhase 2

Recruiting

Leukemia, Acute LymphoblasticPhase 3

Completed

Acute Lymphoblastic Leukemia (ALL)Phase 3

Active, not recruiting

Autoimmune Encephalitis (AE)Approved

Not yet recruiting

B Acute Lymphoblastic Leukemia With T(9;22)(q34.1;q11.2); BCR-ABL1Phase 3

Active, not recruiting

Ph+ ALLPreclinical

Recruiting

Recurrent B Acute Lymphoblastic LeukemiaPhase 3

Active, not recruiting

Acute Lymphoblastic Leukemia, AdultPreclinical

Recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Blincyto

Amgen

Approved

1 2

NTQ5082

NNanjing Chia-tai Tianqing Pharmaceutical

Phase 3

1 3

S1,

CChinese Academy of Medical Sciences

Phase 3

1 4

Romiplostim N01

Qilu Pharmaceutical Co., Ltd.

Phase 3

1 5

Zvs101e

CChigenovo Co., Ltd

Phase 3

1 6

Imlifidase

HHansa Biopharma AB

Phase 3

2 7

INZ-701

IInozyme Pharma

Phase 3

1 8

Efsubaglutide Alfa

SShanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Phase 3

1 9

IBI302

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

1 10

Lenzumestrocel

CCorestemchemon, Inc.

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 2Not yet recruiting

Blinatumomab

NCT06075238

Q4 2026

N/ANot yet recruiting

Acute Lymphoblastic Leukemia

NCT06658938

N/ANot yet recruiting

Transplantation

NCT06504186

PreclinicalActive, not recruiting

Acute Lymphoblastic Leukemia

NCT03114865

Phase 2Recruiting

Acute Lymphoblastic Leukemia

NCT02877303

Phase 1Recruiting

Acute Lymphoblastic Leukemia

NCT04872790

Clinical

Trials by Indication[1]

Acute Lymphoblastic Leukemia45 trials

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

Withdrawn· Novartis logo

Novartis·Phase 3·NCT03628053

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

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

Show 42 more trials

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

Completed·GGoethe University·Phase 2·NCT03109093·83 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

Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06308588·40 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

A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia

Recruiting· Amgen logo

Amgen·Phase 1/2·NCT07134088·104 enrolled

Study of Blinatumomab Administration in Chinese Pediatric Participants With Relapsed/Refractory B Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT06054113·18 enrolled

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

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

Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 1/2·NCT05192889·35 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

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

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

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

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

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

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

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

Completed· Amgen logo

Amgen·Phase 2·NCT01466179·225 enrolled

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

Withdrawn·—·Phase 2·NCT04448834

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

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

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

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

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

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

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

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

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

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 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

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

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

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

Blinatumomab17 trials

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

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

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

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

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

Show 14 more trials

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

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

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

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

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

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

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

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

Immune Reconstitution After Allo-HSCT and Blinatumomab

Unknown status·SSichuan University··NCT06075212·20 enrolled

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

Completed· Amgen logo

Amgen·Phase 1·NCT00274742·76 enrolled

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

Recruiting·CChen Suning·Phase 2·NCT06250959·124 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

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07192237·40 enrolled

Lymphoma4 trials

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

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

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

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

Diffuse Large B-Cell Lymphoma4 trials

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

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

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

Show 1 more trial

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

Completed· Amgen logo

Amgen·Phase 2·NCT01741792·25 enrolled

B-cell acute lymphoblastic leukemia4 trials

Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02458014·36 enrolled

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

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

44 more indications

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

B Acute Lymphoblastic Leukemia3 trials

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

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

Acute Lymphoblastic Leukemia (ALL)3 trials

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

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

Recurrent B Acute Lymphoblastic Leukemia3 trials

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

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

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

Memory2 trials

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

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

Richter Transformation2 trials

Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation

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

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

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

Acute Leukemia2 trials

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

Withdrawn·—·Phase 1·NCT03605589

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

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

Acute Leukemia of Ambiguous Lineage2 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

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

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL12 trials

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

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

Pediatric ALL1 trial

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

Not yet recruiting·—·Phase 2/3·NCT07297914·1,000 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

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

Treatment1 trial

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020)

Not yet recruiting·—·Phase 3·NCT07476729·750 enrolled

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

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

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

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

Transplantation1 trial

The Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous/Allogeneic Transplantation

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·N/A·NCT06504186·20 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

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

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

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

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

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

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

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

BLA BLA125557

Sources

References

[1]
ClinicalTrials.gov — 136 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 (BLA 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

Q3 2026

Q4 2026

Trials by Indication[1]

Acute Lymphoblastic Leukemia45 trials

Blinatumomab17 trials

Lymphoma4 trials

Diffuse Large B-Cell Lymphoma4 trials

B-cell acute lymphoblastic leukemia4 trials

Leukemia3 trials

B Acute Lymphoblastic Leukemia3 trials

Acute Lymphoblastic Leukemia (ALL)3 trials

Recurrent B Acute Lymphoblastic Leukemia3 trials

Myasthenia Gravis2 trials

Memory2 trials

Richter Transformation2 trials

Acute Leukemia2 trials

Chemotherapy2 trials

Relapsed/Refractory2 trials

Acute Leukemia of Ambiguous Lineage2 trials

Systemic Lupus Erythematosus2 trials

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL12 trials

Leukemia, Acute Lymphoblastic2 trials

Pediatric ALL1 trial

Aggressive B-cell NHL1 trial

Older Patients1 trial

Treatment1 trial

Efficacy and Safety1 trial

JAK Inhibitor1 trial

Refractory1 trial

Pediatric1 trial

Stem Cell Transplant1 trial

Adult1 trial

HSCT1 trial

Relapsed or Refractory1 trial

PET1 trial

Multiple Myeloma1 trial

Relapsed/Refractory B-cell ALL1 trial

Transplantation1 trial

Minimal Residual Disease1 trial

Hematopoietic Stem Cell Transplantation1 trial

Newly Diagnosed1 trial

Induction Therapy1 trial

Advanced or Metastatic Solid Tumors1 trial

Philadelphia Chromosome Negative B-cell Precursor Acute Lymphoblastic Leukemia1 trial

B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative1 trial

Acute Lymphoblastic Leukemia, B-precursor1 trial

Down syndrome1 trial

Myeloid Leukemia1 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

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