Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Lymphoma Non-Hodgkin Lymphoma Unknown Primary	NCT ID:	NCT05626322
Trial Phases:	Phase II	Protocol IDs:	C4971003 (primary) NCI-2023-00764 2022-50242721-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Pfizer Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT05626322

Summary

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.

Objectives

This is a multicenter, open-label, Phase 1b/2 study to evaluate the safety, tolerability
and potential clinical benefits of maplirpacept (PF-07901801), an anti-CD47 molecule, in
combination with standard doses of tafasitamab and lenalidomide in participants with
relapsed/refractory (R/R) DLBCL not eligible for or unwilling to undergo high dose
chemotherapy and subsequent autologous stem cell transplantation (ASCT) or unable to
receive approved chimeric antigen receptor T-cell (CAR-T) therapy (for example, due to
logistical limitations).

For Phase 1b, participants must have previously received at least 1 prior systemic
treatment regimen. For Phase 2, participants must have received at least 1 but no more
than 2 prior systemic treatment regimens. All participants must have previously received
an anti-CD20 containing regimen.

Phase 1b will assess dose-limiting toxicities of maplirpacept (PF-07901801) when
administered in combination with tafasitamab and lenalidomide, to select up to 2 doses
for the Phase 2 part of the study. Phase 2 will evaluate safety and efficacy to determine
the recommended Phase 3 dose of Maplirpacept (PF-07901801) to be administered in
combination with tafasitamab and lenalidomide.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.