tafasitamab

Phase 3Monoclonal antibody

tafasitamab is a monoclonal antibody that works as a B-Lymphocyte Antigen CD19 Binding Agent.[2] It is being investigated across 18 indications, with its most advanced program in Phase 3.[1]

tafasitamab is one of 308 small molecule programs targeting Mantle Cell Lymphoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

307

Competitors

Pipeline

Status by Indication[3][1]

Indication

Mantle Cell LymphomaRecruiting

LymphomaTerminated

Marginal Zone LymphomaActive, not recruiting

Hematopoietic and Lymphoid System NeoplasmActive, not recruiting

Lymphoma, B-CellActive, not recruiting

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin LymphomaActive, not recruiting

CNS LymphomaRecruiting

Hematologic MalignanciesRecruiting

Newly DiagnosedActive, not recruiting

Non-Hodgkins LymphomaActive, not recruiting

Mantle Cell LymphomaPhase 2

Recruiting

LymphomaPhase 2

Terminated

Marginal Zone LymphomaPhase 2

Active, not recruiting

Hematopoietic and Lymphoid System NeoplasmPreclinical

Active, not recruiting

Lymphoma, B-CellPhase 1

Active, not recruiting

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin LymphomaPhase 2

Active, not recruiting

CNS LymphomaPreclinical

Recruiting

Hematologic MalignanciesPhase 2

Recruiting

Newly DiagnosedPhase 3

Active, not recruiting

Non-Hodgkins LymphomaPhase 2

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

tafasitamab

Incyte

Phase 3

5 2

Zofran

Novartis

Preclinical

2 3

Norvir

AbbVie

Preclinical

1 4

Cabenuva

GSK

Preclinical

1 5

Nuvigil

NNuvo Research GmbH

Preclinical

1 6

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

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

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Non-Hodgkins Lymphoma

NCT04661007

Phase 2Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04974216

Phase 2Active, not recruiting

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma

NCT05821088

Phase 1Active, not recruiting

Lymphoma, B-Cell

NCT04161248

Q1 2027

PreclinicalActive, not recruiting

Diffuse Large B-Cell Lymphoma

NCT05455697

Phase 2Active, not recruiting

Diffuse Large B-Cell Lymphoma

NCT04978584

Clinical

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma9 trials

A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Completed· Incyte logo

Incyte·Phase 2/3·NCT02763319·453 enrolled

Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Recruiting·BBeijing InnoCare Pharma Tech Co., Ltd.·Phase 3·NCT06521255·244 enrolled

Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older

Active, not recruiting·TThe Lymphoma Academic Research Organisation·Phase 2·NCT04974216·71 enrolled

Show 6 more trials

Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)

Withdrawn·KKaryopharm Therapeutics Inc·Phase 1/2·NCT04607772

Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04978584·62 enrolled

Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT05429268·82 enrolled

Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Terminated· Pfizer logo

Pfizer·Phase 1/2·NCT05626322·6 enrolled

TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma

Not yet recruiting·BBrown University·Phase 2·NCT07502872·30 enrolled

Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR With Standard Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma

Active, not recruiting·UUniversity of Washington·Preclinical·NCT05455697·33 enrolled

Lymphoma5 trials

A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07030699·27 enrolled

Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)

Terminated·XXencor, Inc.·Phase 2·NCT05328102·3 enrolled

Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05890352·227 enrolled

Show 2 more trials

A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT03930953·438 enrolled

Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma

Withdrawn· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT04882163

Chronic Lymphocytic Leukemia3 trials

A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Terminated· Incyte logo

Incyte·Phase 1/2·NCT04809467·54 enrolled

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

Active, not recruiting·—·Phase 2·NCT05718869·26 enrolled

Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Recruiting·OOHSU Knight Cancer Institute·Phase 1·NCT05943496·27 enrolled

Lenalidomide3 trials

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Active, not recruiting· Incyte logo

Incyte·Phase 1/2·NCT05222555·53 enrolled

Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Recruiting·UUniversity of Cologne·Phase 2·NCT05583071·20 enrolled

Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06760156·28 enrolled

Mantle Cell Lymphoma3 trials

A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05788289·4 enrolled

Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recruiting·—·Phase 2·NCT05910801·100 enrolled

Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma

Recruiting·—·Phase 1/2·NCT06029309·27 enrolled

21 more indications

Newly Diagnosed2 trials

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04824092·899 enrolled

Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL

Completed·MMorphoSys AG·Phase 1·NCT04134936·66 enrolled

Follicular Lymphoma2 trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Active, not recruiting· Incyte logo

Incyte·Phase 3·NCT04680052·654 enrolled

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT06792825·65 enrolled

Acute Lymphoblastic Leukemia1 trial

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

Recruiting·UUniversity of Washington·Phase 2·NCT05453500·30 enrolled

Real-world Study1 trial

A Real-world Study of Tafasitamab in Combination With Lenalidomide in Patients withR/R DLBCL

Unknown status·ZZhao Weili··NCT05883709·15 enrolled

Hematologic Malignancies1 trial

Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Recruiting· Incyte logo

Incyte·Phase 2·NCT06465433·25 enrolled

Efficacy1 trial

Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

Completed·MMorphoSys AG·Phase 2·NCT02639910·24 enrolled

Non-Hodgkins Lymphoma1 trial

To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Active, not recruiting·IIncyte Biosciences Japan GK·Phase 1/2·NCT04661007·72 enrolled

Blood Cancer1 trial

A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.

Withdrawn·EEpizyme, Inc.·Phase 1/2·NCT05205252

Leukemia1 trial

Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia

Recruiting·UUniversity Hospital Tuebingen·Phase 1/2·NCT05366218·20 enrolled

Autoimmune Disorders1 trial

Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders

Recruiting·MM.D. Anderson Cancer Center·Phase 1/2·NCT06434363·47 enrolled

Post-Transplant Lymphoproliferative Disorder1 trial

Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder

Recruiting·TTimothy Voorhees·Phase 2·NCT05786040·28 enrolled

Relapsed or Refractory1 trial

realMIND: Observational Study on Safety and Effectiveness of Tafasitamab in Combination With Lenalidomide in Patients With Relapsed or Refractory DLBCL

Recruiting· Incyte logo

Incyte··NCT04981795·100 enrolled

Safety and Efficacy1 trial

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Completed·MMorphoSys AG·Phase 2·NCT02399085·81 enrolled

Chronic Graft Versus Host Disease1 trial

Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation

Suspended·—·Phase 1·NCT05993611·27 enrolled

Hodgkin Lymphoma1 trial

A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05615636·36 enrolled

Classic Follicular Lymphoma1 trial

TREND-FL: Tafasitamab and Rituximab to Enhance Outcomes in Patients With Newly Diagnosed Follicular Lymphoma

Not yet recruiting·UUniversity of Washington·Phase 2·NCT07731789·30 enrolled

Non-Hodgkin Lymphoma1 trial

Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma

Recruiting·PPaolo Caimi, MD·Phase 1·NCT07225439·15 enrolled

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma1 trial

A Phase II Trial of Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma

Active, not recruiting·DDavid Bond, MD·Phase 2·NCT05821088·37 enrolled

CNS Lymphoma1 trial

A Phase I/II Study of Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

Recruiting·JJames Rubenstein·Preclinical·NCT05351593·35 enrolled

Lymphoma, B-Cell1 trial

A Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

Active, not recruiting·CCanadian Cancer Trials Group·Phase 1·NCT04161248·40 enrolled

Unspecified1 trial

Study of Acalabrutinib and Tafasitamab in MZL Patients

Active, not recruiting·IInternational Extranodal Lymphoma Study Group (IELSG)·Phase 2·NCT04646395·26 enrolled

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for tafasitamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — tafasitamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for tafasitamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: B-Lymphocyte Antigen CD19 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Incyte

tafasitamab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma9 trials

Lymphoma5 trials

Chronic Lymphocytic Leukemia3 trials

Lenalidomide3 trials

Mantle Cell Lymphoma3 trials

Newly Diagnosed2 trials

Follicular Lymphoma2 trials

Acute Lymphoblastic Leukemia1 trial

Real-world Study1 trial

Hematologic Malignancies1 trial

Efficacy1 trial

Non-Hodgkins Lymphoma1 trial

Blood Cancer1 trial

Leukemia1 trial

Autoimmune Disorders1 trial

Post-Transplant Lymphoproliferative Disorder1 trial

Relapsed or Refractory1 trial

Safety and Efficacy1 trial

Chronic Graft Versus Host Disease1 trial

Hodgkin Lymphoma1 trial

Classic Follicular Lymphoma1 trial

Non-Hodgkin Lymphoma1 trial

B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma1 trial

CNS Lymphoma1 trial

Lymphoma, B-Cell1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

Related News