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Finding studies
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UCSF HDFCCC Cancer Immunotherapy Program
CONTACT
Lead
C. Babis Andreadis
With
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. 2. To describe the efficacy of chimeric antigen receptor T cells targeting CD-19 in patients with relapsed or refractory CD19+ B cell NHL. 3. To evaluate the feasibility of CD19 CAR T cell manufacturing for patients with relapsed or refractory CD19+ B cell NHL of local manufacturing and ability to produce adequate quantities of vector positive T-cells. OUTLINE Participants will be enrolled to either the dose escalation or dose expansion cohorts. Dose Escalation: CLOSED TO ENROLLMENT Dose Expansion: The dose expansion phase of the study will be limited to two disease-specific cohorts: * Cohort B: Participants with Burkitt lymphoma (B). * Cohort M/W: Participants with Marginal Zone Lymphoma (MZL) and Waldenström Macroglobulinemia (WM). Participants will receive an infusion of Anti-CD19 CAR-T cells during the main study and will be followed for 12 months before being transferred into long term follow-up during years 1 to 15.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
