Overview

Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Status:
Recruiting
Trial end date:
2026-08-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objectives of this study are: - To investigate the safety and tolerability, and to define the recommended Phase 2 dose and schedule (RP2DS) for magrolimab in combination with rituximab and for magrolimab in combination with rituximab, gemcitabine, and oxaliplatin (R-GemOx). - To evaluate the efficacy of magrolimab in combination with rituximab in participants with indolent lymphoma and diffuse large B-cell lymphoma (DLBCL) and to evaluate the efficacy of magrolimab in combination with R-GemOx in aspartate aminotransferase (ASCT) ineligible DLBCL participants.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Forty Seven, Inc.
Gilead Sciences
Collaborator:
The Leukemia and Lymphoma Society
Treatments:
Gemcitabine
Magrolimab
Oxaliplatin
Rituximab
Criteria
Key Inclusion Criteria:

- Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard
approved therapies

- DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL)
expressing CD 20, relapsed or refractory to at least 2 prior lines treatment
containing anti-CD20 therapy

- Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or
refractory to standard approved therapies

- DLBCL chemotherapy combination cohort: De novo or transformed diffuse large B-cell
lymphoma (DLBCL), relapsed or refractory to 1-3 prior lines of treatment

- Adequate performance status and hematological, liver and kidney functions

- Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy

Key Exclusion Criteria:

- Active brain metastases

- Prior allogeneic hematopoietic cell transplantation

- Prior treatment with CD47 or signal regulatory protein alpha (SIRPĪ±) targeting agents

- Second malignancy within the last 3 years

- Known active or chronic hepatitis B or C infection or HIV

- Pregnancy or active breastfeeding

- Prior chimeric antigen receptor (CAR-T) therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.