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DRUG:

Monjuvi (tafasitamab-cxix)

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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
9d
New P2/3 trial
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LDH elevation
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Monjuvi (tafasitamab-cxix)
29d
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
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TP53 (Tumor protein P53) • KMT2A (Lysine Methyltransferase 2A) • AFF1 (AF4/FMR2 Family Member 1) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1)
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TP53 mutation • CD19 positive
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Monjuvi (tafasitamab-cxix)
1m
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
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Venclexta (venetoclax) • cisplatin • gemcitabine • dexamethasone • Rituxan Hycela (rituximab/hyaluronidase) • Monjuvi (tafasitamab-cxix) • Columvi (glofitamab-gxbm)
1m
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
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BCL2 (B-cell CLL/lymphoma 2) • CCND1 (Cyclin D1) • BCL6 (B-cell CLL/lymphoma 6)
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Chr t(11;14)
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parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
3ms
New P1/2 trial
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Epkinly (epcoritamab-bysp) • Monjuvi (tafasitamab-cxix)
3ms
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
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Imbruvica (ibrutinib) • lenalidomide • Monjuvi (tafasitamab-cxix)
3ms
Enrollment open
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Monjuvi (tafasitamab-cxix)
4ms
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
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BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6)
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carboplatin • lenalidomide • cyclophosphamide • ifosfamide • etoposide IV • Monjuvi (tafasitamab-cxix)
4ms
Trial suspension • First-in-human
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Monjuvi (tafasitamab-cxix)
4ms
Enrollment closed • First-in-human
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Monjuvi (tafasitamab-cxix)
4ms
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
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IGH (Immunoglobulin Heavy Locus)
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clonoSEQ
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Gazyva (obinutuzumab) • Calquence (acalabrutinib) • Monjuvi (tafasitamab-cxix)
4ms
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
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clonoSEQ
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Brukinsa (zanubrutinib) • Monjuvi (tafasitamab-cxix)