LAST UPDATED
May 29, 2025
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
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
PROTOCOL 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 autologous stem cell transplant (ASCT) ineligible DLBCL participants.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Non Hodgkin Lymphoma
Gender
N/A
Date
November 2016 - March 2024
Study Type
Interventional
Study Phase
Phase 1, Phase 2
Product
Magrolimab, Rituximab, Gemcitabine, Oxaliplatin, Allopurinol
Eligibility information
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 cluster of differentiation (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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (20)
University of Alabama At Birmingham (Uab)
Birmingham, Alabama, United States, 35924
City of Hope National Medical Center
Duarte, California, United States, 91010
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
National Institutes of Health Clinical Center/ National Cancer Institute
Bethesda, Maryland, United States, 20892
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States, 63110
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
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