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

  • Interventional
  • Recruiting
  • NCT02953509
Eligibility Details Visit Clinicaltrials.gov

A Phase 1b/2 Trial of Hu5F9-G4 in Combination With Rituximab or Rituximab + Chemotherapy in Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT02953509

IRB#IRB16-1265

Lead SponsorGilead Sciences

Lead PhysicianSonali Smith

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting