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    DRUG:

    Monjuvi (tafasitamab-cxix)

    i
    Other names: MOR-208, MOR 208, MOR00208, INCMOR0208, ICP-B04, ICPB04, ICP B04, INCMOR-0208, INCMOR 0208, MOR 00208, XENP5574, XENP 5574, XmAb 5574, XmAb-5574, INCA000585, INCA-000585, MOR208, MOR-00208, XmAb5574, XENP-5574
    Company:
    Incyte, InnoCare, Knight Therap, Specialised Therap, Xencor
    Drug class:
    CD19 inhibitor
    Related drugs:
    16h
    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)
    4d
    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)
    8d
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (clinicaltrials.gov)
    P1, N=27, Recruiting, OHSU Knight Cancer Institute | Trial completion date: Jan 2027 --> Jan 2028 | Trial primary completion date: Jan 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    clonoSEQ
    |
    Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Monjuvi (tafasitamab-cxix)
    3ms
    Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | Trial completion date: Oct 2025 --> Apr 2026 | Trial primary completion date: Oct 2025 --> Apr 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    clonoSEQ
    |
    Brukinsa (zanubrutinib) • Monjuvi (tafasitamab-cxix)
    3ms
    Exploring CD19-targeted Immunotherapy Strategies for Human B-cell Lymphoma. (PubMed, Arch Razi Inst)
    There are several FDA-approved anti-CD19 CAR-T cells, including Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel, as well as anti-CD19 monoclonal antibodies (mABs), such as loncastuximab tesirine and tafasitamab...Blinatumomab, the inaugural FDA-approved antibody to be produced using BiTE technology, has demonstrated notable benefits in clinical trials investigating its use in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)...Furthermore, we engaged in a discourse on the various treatment options concerning CD19 targeting, accompanied by an exposition of the pertinent clinical studies. In this regard, the efficacy, safety, and limitations of each option were thoroughly delineated.
    Review • Journal
    |
    CD20 (Membrane Spanning 4-Domains A1) • TNFRSF8 (TNF Receptor Superfamily Member 8) • CD79B (CD79b Molecule) • CD52 (CD52 Molecule)
    |
    Blincyto (blinatumomab) • Yescarta (axicabtagene ciloleucel) • Breyanzi (lisocabtagene maraleucel) • Kymriah (tisagenlecleucel-T) • Zynlonta (loncastuximab tesirine-lpyl) • Monjuvi (tafasitamab-cxix)