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.

Lead Sponsor:

Forty Seven, Inc.

Collaborator: The Leukemia and Lymphoma Society

Stanford Investigator(s):

Intervention(s):

  • Drug: Hu5F9-G4
  • Drug: Rituximab

Phase:

Phase 1/Phase 2

Eligibility


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),
   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
   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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Thu Tran
650-723-0530
Recruiting