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

NCT05626322 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: C49710032022-502427-21-00
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

DLBCL; Lymphoma; Relapsed; Refractory; CD19; CD47; Maplirpacept; Tafasitamab; Lenalidomide

Outcome Measures

Primary Outcomes (1)

• Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)

  DLTs included: Hematological: Grade (G) 4 thrombocytopenia (\<25,000/microliter \[mcL\]) lasting \>=72 hours or a platelet count \<=10,000/mcL at any time, unexplained by underlying disease; \>=G3 thrombocytopenia associated with \>=G2 bleeding, unexplained by underlying disease. G4 anemia; unexplained by underlying disease; G4 neutropenia lasting \>=7 days, unexplained by underlying disease; G3 febrile (\>38.3-degree Celsius \[C\]) neutropenia lasting \>=7 days, unexplained by underlying disease; G4 febrile neutropenia unexplained by underlying disease. Non-hematological: any treatment-related \>=G3 non-hematologic toxicity; Other \>=G2 PF-07901801-related non-hematologic toxicities that, in the opinion of the investigator, required a dose reduction or discontinuation of PF-07901801 were considered a DLT.

  Cycle 1 (28 Days)

Secondary Outcomes (12)

• Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

• Phase 1b: Number of Participants With Serious Treatment Emergent Adverse Events

  From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

• Phase 1b: Number of Participants With Treatment-Related AEs

  From Day 1 of dosing up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

• Phase 1b: Number of Participants With Grade Shift From Baseline in Hematology Parameters to Any Time Post-baseline

  From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

• Phase 1b: Number of Participants With Grade Shift From Baseline in Chemistry Parameters to Any Time Post Baseline

  From baseline (latest non-missing value from pre-treatment period) up to 35 days post last dose of PF-07901801 and/or lenalidomide or 90 days after the last dose of tafasitamab, whichever was longer (maximum up to 14.2 months of exposure)

Study Arms (2)

Phase 1b

EXPERIMENTAL

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.

Drug: Maplirpacept; Drug: Tafasitamab; Drug: Lenalidomide

Phase 2

EXPERIMENTAL

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).

Drug: Maplirpacept; Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Maplirpacept DRUG

Intravenous infusion

Also known as: PF-07901801, TTI-622

Phase 1b; Phase 2

Tafasitamab DRUG

Intravenous infusion

Also known as: Minjuvi, Monjuvi

Phase 1b; Phase 2

Lenalidomide DRUG

Oral (by mouth)

Also known as: Revlimid

Phase 1b; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, uncontrolled bacterial, fungal or viral infection.

Sponsors & Collaborators

• Pfizer: lead
• MorphoSys AG: collaborator
• Incyte Corporation: collaborator

Study Sites (7)

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Dong-A University Hospital

Busan, Pusan-kwangyǒkshi, 49201, South Korea

Location

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Recurrence

Interventions

tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer CT.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label/randomized

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: August 4, 2023
• Primary Completion: August 12, 2024
• Study Completion: May 1, 2025
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (1); KR (2); US (4)