Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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 (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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

178

Study ID:

NCT02953509

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 19 Locations for this study

See Locations Near You

University of Alabama At Birmingham (Uab)
Birmingham Alabama, 35924, United States
City of Hope National Medical Center
Duarte California, 91010, United States
Stanford Cancer Center
Stanford California, 94305, United States
Georgia Cancer Center at Augusta University
Augusta Georgia, 30912, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
National Institutes of Health Clinical Center/ National Cancer Institute
Bethesda Maryland, 20892, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
The Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Princess Alexandra Hospital
Brisbane Queensland, 4102, Australia
St. Vincent's Hospital Melbourne
Melbourne Victoria, 3065, Australia
Linear Clinical Research Ltd
Nedlands Western Australia, 6009, Australia
The Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

178

Study ID:

NCT02953509

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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