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C4971006: A Study to Learn About the Effects of 2 Study Medicines (Maplirpacept [PF-07901801] and Glofitamab) When Given Together in People With Relapsed or Refractory Diffuse Large B Cell Lymphoma
EU CTIS ID: 2022-502822-41-00
What this study is testing
Phase 1b: to assess dose limiting toxicities (DLTs), safety and tolerability of PF-07901801 and glofitamab, after a single dose of obinutuzumab in adult participants with R/R DLBCL in order to select up to 2 doses of PF-07901801 for further evaluation in Phase 2 of the study. Phase 2: to assess the clinical anti-tumor activity of PF 07901801 in combination with glofitamab after a single dose of obinutuzumab in adult participants with R/R DLBCL.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults with histologically confirmed DLBCL and relapsed or refractory disease
- Participant is not a candidate or unwilling to undergo high dose chemotherapy and subsequent autologous stem cell transplant or unable to receive approved chimeric antigen receptor T-cell therapy (CAR-T).
- Measurable disease: at least 1 site of measurable PET-avid disease per Lugano 2014 classification.
- Prior treatment must include at least 2 lines of systemic therapy (for Phase 2: at least 2 but no more than 4 prior lines of systemic therapy). Prior therapy must include an anti-CD20 containing regimen.
- Adequate hematologic, hepatic and renal function.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
You likely can't join if
- High-grade B-Cell lymphoma NOS or High-grade B-Cell lymphoma with MYC and BCL2 rearrangements.
- Known or suspected primary or secondary CNS lymphoma or meningeal involvement; history of multifocal leukoencephalopathy; history of CNS disease.
- Significant cardiac/cardiovascular/thromboembolic disease.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) not resolved within 72 hours prior to study enrollment.
- Prior treatment with anti-CD47 and/or anti-SIRPα therapy and/or prior glofitamab or anti-CD20xCD3 containing regimen.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Japan
- Australia
- Taiwan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Japan; Australia; Taiwan; United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.