Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
A PHASE 1b/2 STUDY OF PF-07901801, A CD47 BLOCKING AGENT, WITH TAFASITAMAB AND LENALIDOMIDE FOR PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION
Sponsor: Pfizer + MorphoSys AG, Incyte Corporation
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 Days)
Secondary Endpoints
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events
Phase 1b: Number of Participants With Treatment-Related AEs
Eligibility Criteria
Key Inclusion Criteria: * Histologically confirmed diagnosis of DLBCL * Relapsed or refractory disease * Participant is not be a candidate for or is unwilling to undergo high dose chemotherapy and subsequent stem cell transplant and/or is unable to receive chimeric antigen receptor (CAR) T-cell therapy * Previous treatment with at least one prior line of systemic therapy (for phase 2, at least 1 and no more than 2 prior lines of systemic therapy). Prior therapy must include an anti-CD20 antibody. * Adequate bone marrow, hepatic and renal function * Eastern Cooperative Oncology Group (ECOG) ≤2 * Must provide a tumor tissue sample (fresh or archival, collected prior to start of treatment) for biomarker analysis Key Exclusion Criteria: * Prior treatment with an anti-CD47 or anti-CD19 (other than CAR T) or immunomodulatory agents * Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment * Participants with active, uncontrolle…
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