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Number of Visits: Unknown

Duration: Up to 24 months

6 Participants Needed

Maplirpacept + Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma

Recruiting at 21 trial locations

Overseen ByPfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pfizer

Must not be taking: Anti-CD47, Anti-CD19, Immunomodulatory

Disqualifiers: Active infections, Recent stem cell transplant, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn about the effects of three study medicines \[maplirpacept (PF-07901801), tafasitamab, and lenalidomide\] when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that: * is relapsed (has returned after last treatment) or * is refractory (has not responded to last treatment) DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking participants who are unable or unwilling to undergo an autologous stem cell transplantation (when doctors put healthy blood cells back into your body) or CAR-T immune cell therapy. Everyone in this study will receive three medicines: maplirpacept (PF-07901801), tafasitamab and lenalidomide. Participants will receive maplirpacept (PF-07901801) and tafasitamab at the study clinic by intravenous (IV) infusion (given directly into a vein) and lenalidomide will be taken by mouth at home. Study interventions will be administered in 28-day cycles. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every two weeks. Tafasitamab will administered on Days 1, 4, 8, 15 and 22 in cycle 1, weekly in cycles 2 and 3 and then every 2 weeks in cycle 4 and beyond. Lenalidomide will be taken every day for Days 1 to 21 of each 28-day cycle for the first 12 cycles. Participants can continue to take maplirpacept (PF-07901801) and tafasitamab until their lymphoma is no longer responding. Lenalidomide is discontinued after 12 cycles. Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive approved doses of tafasitamab and lenalidomide. We will compare the experiences of people receiving different doses of PF-07901801. This will help us to determine what dose is safe and effective when combined with the other 2 study medicines.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has either come back or didn't respond to treatment. They should have tried at least one other therapy but can't or don't want to do certain stem cell transplants or CAR-T therapy. Participants need to provide a tumor sample and have good enough bone marrow, liver, and kidney function.

Inclusion Criteria

I can provide a sample of my tumor for testing before treatment starts.

My diagnosis is diffuse large B-cell lymphoma.

My liver, kidneys, and bone marrow are working well.

See 4 more

Exclusion Criteria

I do not have any ongoing serious infections.

I had a stem cell transplant less than 12 weeks ago.

I have previously been treated with anti-CD47, anti-CD19 (not CAR T), or immunomodulatory agents.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maplirpacept (PF-07901801), tafasitamab, and lenalidomide in 28-day cycles. Maplirpacept is given weekly for the first three cycles and then every two weeks. Tafasitamab is administered on Days 1, 4, 8, 15, and 22 in cycle 1, weekly in cycles 2 and 3, and then every 2 weeks in cycle 4 and beyond. Lenalidomide is taken daily for Days 1 to 21 of each 28-day cycle for the first 12 cycles.

Up to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may continue to take maplirpacept (PF-07901801) and tafasitamab until their lymphoma is no longer responding.

Long-term

Treatment Details

Interventions

Lenalidomide
PF-07901801
Tafasitamab

Trial OverviewThe study tests the combined effect of three drugs: Maplirpacept (PF-07901801), Tafasitamab, and Lenalidomide in patients with relapsed/refractory DLBCL. Treatments are given in cycles; Maplirpacept by IV infusion weekly then biweekly, Tafasitamab IV on specific days early then biweekly, and daily oral Lenalidomide for part of each cycle.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment3 Interventions

Participants will be randomized to 1 of 2 different dose levels of maplirpacept (PF-07901801) which will be administered in combination with standard doses of tafasitamab and lenalidomide. Approximately 50 participants will be enrolled (25 per dose).

Group II: Phase 1bExperimental Treatment3 Interventions

Participants will be allocated to sequential dose levels of maplirpacept (PF-07901801), administered in combination with standard doses of tafasitamab and lenalidomide, to select two doses for further evaluation in Phase 2. Approximately 20 participants will be enrolled.

Lenalidomide is already approved in European Union, United States for the following indications:

Approved in European Union as Revlimid for:

Multiple myeloma
Myelodysplastic syndromes
Mantle cell lymphoma
Follicular lymphoma
Marginal zone lymphoma

Approved in United States as Revlimid for:

Multiple myeloma
Myelodysplastic syndromes
Mantle cell lymphoma
Follicular lymphoma
Marginal zone lymphoma

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Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

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