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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

Trial Status: Active

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.

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

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

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Leslie L. Popplewell
Phone: 800-826-4673
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Maryland

Bethesda
National Institutes of Health Clinical Center
Status: ACTIVE
Contact: Mark Jason Roschewski
Phone: 240-760-6183

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Gilead

  • Primary ID 5F9003
  • Secondary IDs NCI-2017-00032, 2016-003408-29
  • Clinicaltrials.gov ID NCT02953509