A Phase 1 Clinical Trial of Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma
C. Babis Andreadis
Summary
This study will assess safety and feasibility of infusing genetically modified autologous T cells transduced to express a chimeric antigen receptor targeting the B cell surface antigen Cluster of Differentiation 19 (CD19).
Description
This is an open-label, pilot, phase 1 study to determine the safety profile of anti-CD19 CAR-T cell infusion in participants with R/R B-cell NHL. PRIMARY OBJECTIVES 1. To evaluate the safety of administering chimeric antigen receptor T cells targeting CD-19 to patients with relapsed or refractory CD19+ B-cell non-Hodgkin lymphoma (NHL). 2. To determine the recommended phase 2 dose (RP2D) for this cellular therapy. SECONDARY OBJECTIVES 1. To assess the safety and toxicity of cell collection and infusion of CAR-T cells targeting CD19 in patients with relapsed or refractory CD19+ B cell NHL.…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
THE DOSE ESCALATION COHORT IS CLOSED TO FURTHER ENROLLMENT. Inclusion Criteria: Dose expansion Cohorts: Cohort B (Burkitt): 1. Participants must have a diagnosis of relapsed or refractory Burkitt Lymphoma * Participants with Burkitt lymphoma must have relapsed or failed to respond to at least 1 prior line of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline. * No significant circulating disease, defined as an elevated total lymphocyte count above the upper limit of normal (ULN) due to the presence of malignant cells. 2. Partic…
Interventions
- DrugFludarabine
Given intravenously (IV)
- DrugCyclophosphamide
Given intravenously (IV)
- Biologicalanti-CD19 CAR-T cells
Single infusion
Location
- University of California, San FranciscoSan Francisco, California