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- (5F9003) A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Clinical Trial
(5F9003) A Phase 1b/2 Trial of Hu5F9-G4 in Combination with Rituximab in Patients with Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This trial will test an experimental drug called Hu5F9-G4, in combination with standard rituximab, gemcitabine, and oxaliplatin/chemotherapy combination (referred to as R-GemOx). Hu5F9-G4 is a type of protein called an antibody, and it is being tested to see if will help the body's immune system find and destroy cancer cells. The trial will have two phases: Phase 1b will test the safety and tolerability of increasing doses of Hu5F9-G4 in combination with ritixumab. Phase 2 will test Hu5F9-G4 in combination with rituximab to see how effectively it treats indolent lymphoma or diffuse large B-cell lymphoma.
- Lymphatic System
- CD47
- Diffuse Large B-cell Lymphoma (DLBCL)
- Hu5F9-G4
- Indolent Lymphoma
- Non-Hodgkin's Lymphoma (NHL)
Eligibility Criteria
- Inclusion criteria: Phase 1b: B-cell non-Hodgkin's lymphoma (NHL), relapsed or not responsive to standard approved therapies Phase 2: Diffuse large B-cell lymphoma (DLBCL), relapsed or not responsive to 1-2 lines of treatment or autologous hematopoietic cell transplantation Phase 2: Indolent lymphoma, relapsed or not responsive to standard approved therapies Exclusion Criteria: Active brain metastases Prior allogeneic hematopoietic cell transplantation Prior treatment with CD47 or signal regulatory protein alpha (SIRP?) targeting agents Second malignancy within the last 3 years Known active or chronic hepatitis B or C infection or HIV Pregnancy or active breastfeeding Full inclusion/exclusion criteria may be found on ClinicalTrials.gov, or by contacting our clinical trials office.
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