Study Details

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.

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Non Hodgkin Lymphoma

Gender

N/A

Date

November 2016 - May 2024

Study Type

Interventional

Study Phase

Phase 1, Phase 2

Product

Magrolimab, Rituximab, Gemcitabine, Oxaliplatin

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 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

Stanford Cancer Center

Stanford, California, United States, 94305

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 Michigan

Ann Arbor, Michigan, United States, 48109

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States, 55455

Washington University School of Medicine Siteman Cancer Center

Saint 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

Princess Alexandra Hospital

Brisbane, Queensland, Australia, 4102

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia, 3065

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia, 6009

The Churchill Hospital

Oxford, United Kingdom, OX3 7LE

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

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