Trial Search Results
Trial of Hu5F9-G4 in Combination With Rituximab in Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This Phase 1b/2 trial will evaluate Hu5F9-G4 in combination with rituximab. Hu5F9-G4 is a monoclonal antibody which is designed to block a protein called CD47, which is widely expressed on human cancer cells. Blocking CD47 with Hu5F9-G4 may enable the body's immune system to find and destroy the cancer cells. Rituximab is a monoclonal antibody drug that is used for treatment of non-Hodgkin's lymphoma and other types of cancer.
The major aims of the trial are: (Phase 1b) to investigate the safety and tolerability of sequential dose cohorts and to determine a recommended Phase 2 dose for Hu5F9-G4 in combination with rituximab, and (Phase 2) to evaluate the efficacy of Hu5F9-G4 in combination with rituximab in patients with indolent lymphoma or diffuse large B-cell lymphoma as measured by the overall response rate.
Stanford is currently accepting patients for this trial.
Forty Seven, Inc.
Collaborator: The Leukemia and Lymphoma Society
- Drug: Hu5F9-G4
- Drug: Rituximab
Phase 1/Phase 2
- Phase 1b only: B-cell non-Hodgkin's lymphoma (NHL), relapsed or refractory to standard
- DLBCL Phase 2 cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL),
relapsed or refractory to frontline or second line treatment or autologous
hematopoietic cell transplantation
- Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or
refractory to standard approved therapies
- Adequate performance status and hematological, liver and kidney functions
- Phase 2 only: Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor
- 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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study