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Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Not Recruiting
Trial ID: NCT02953509,,
Purpose
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 autologous stem cell transplant
(ASCT) ineligible DLBCL participants.
Official Title
A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Neel K. Gupta
Clinical Associate Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Eligibility
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 (SIRPα) 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.
Intervention(s):
drug: Rituximab
drug: Oxaliplatin
drug: Magrolimab
drug: Gemcitabine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cheryl Chang
650-725-6432