^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Monjuvi (tafasitamab-cxix)

    i
    Other names: MOR208, MOR-00208, XmAb5574, XENP-5574, MOR-208, INCMOR 0208, MOR 00208, XENP5574, XENP 5574, XmAb 5574, XmAb-5574, INCA000585, INCA-000585, MOR 208, MOR00208, INCMOR0208, ICP-B04, ICPB04, ICP B04, INCMOR-0208
    Company:
    Incyte, InnoCare, Knight Therap, Specialised Therap, Xencor
    Drug class:
    CD19 inhibitor
    Related drugs:
    7d
    TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Brown University
    New P2 trial
    |
    BCL2 (B-cell CLL/lymphoma 2) • CD4 (CD4 Molecule) • IRF4 (Interferon regulatory factor 4)
    |
    Gazyva (obinutuzumab) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq) • Columvi (glofitamab-gxbm)
    1m
    Management of Primary Refractory Diffuse Large B-Cell Lymphoma in Patients Unsuitable for CAR T-Cell Therapy. (PubMed, Eur J Haematol)
    Conventional platinum-based or gemcitabine- and bendamustine-containing regimens retain a role for short-term disease control but offer limited durability. In contrast, novel antibody-based therapies, including polatuzumab-containing combinations, loncastuximab tesirine, and tafasitamab plus lenalidomide, have expanded treatment options with improved tolerability. Most notably, CD20 × CD3 bispecific antibodies represent a major therapeutic advance, providing off-the-shelf immune engagement with predominantly outpatient administration. From a practical perspective, early identification of reversible barriers to CAR T-cell therapy and timely use of bispecific antibodies or other antibody-based regimens are critical to achieve rapid disease control, preserve organ function, and, when feasible, restore eligibility for cellular therapy.
    Review • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    gemcitabine • lenalidomide • bendamustine • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix) • Polivy (polatuzumab vedotin-piiq)
    1m
    INCA000585-201: Phase 2a Study of Tafasitamab in Adults With Primary Autoimmune Blood Cell Disorders (2025-521286-27-00)
    P2/3, N=20, Not yet recruiting, Incyte Corp.
    New P2/3 trial
    |
    LDH elevation
    |
    Monjuvi (tafasitamab-cxix)
    2ms
    Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia (clinicaltrials.gov)
    P1/2, N=20, Recruiting, University Hospital Tuebingen | Trial completion date: Mar 2027 --> Feb 2029 | Trial primary completion date: Mar 2027 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    TP53 (Tumor protein P53) • KMT2A (Lysine Methyltransferase 2A) • AFF1 (AF4/FMR2 Family Member 1) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1)
    |
    TP53 mutation • CD19 positive
    |
    Monjuvi (tafasitamab-cxix)
    2ms
    CCTG LY18-A: Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma (clinicaltrials.gov)
    P1, N=18, Recruiting, Canadian Cancer Trials Group | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
    2ms
    topMIND: 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) (clinicaltrials.gov)
    P1/2, N=54, Terminated, Incyte Corporation | Completed --> Terminated; A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.
    Trial termination • Pan tumor
    |
    BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
    |
    Chr t(11;14)
    |
    parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    4ms
    Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    Epkinly (epcoritamab-bysp) • Monjuvi (tafasitamab-cxix)
    4ms
    Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL (clinicaltrials.gov)
    P2, N=41, Completed, Ohio State University Comprehensive Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2025 --> May 2025 | Trial primary completion date: Aug 2025 --> May 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • lenalidomide • Monjuvi (tafasitamab-cxix)
    4ms
    Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders (clinicaltrials.gov)
    P2, N=56, Recruiting, Incyte Corporation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Monjuvi (tafasitamab-cxix)
    5ms
    Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma (clinicaltrials.gov)
    P2, N=37, Recruiting, David Bond, MD | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
    |
    carboplatin • lenalidomide • cyclophosphamide • ifosfamide • etoposide IV • Monjuvi (tafasitamab-cxix)
    5ms
    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 (clinicaltrials.gov)
    P1, N=27, Suspended, City of Hope Medical Center | Active, not recruiting --> Suspended
    Trial suspension • First-in-human
    |
    Monjuvi (tafasitamab-cxix)
    5ms
    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 (clinicaltrials.gov)
    P1, N=27, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting
    Enrollment closed • First-in-human
    |
    Monjuvi (tafasitamab-cxix)