P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Trial Parameters
Brief Summary
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies
Eligibility Criteria
Inclusion Criteria 1. Must have signed written, informed consent. 2. Males or females ≥ 18 years of age. 3. Must have prior biopsy proven confirmed diagnosis of DLBCL NOS (including DLBCL arising from indolent lymphomas), HGBL, PMBCL,and tFL or follicular lymphoma Grade 3B. 4. Diagnosis of the disease based on WHO 2016 (Swerdlow, 2016) criteria. 5. Subjects must have measurable disease as defined by Lugano 2016 criteria (Cheson, 2016). 6. Must have relapsed/refractory disease and have received adequate prior anti-cancer therapy, as defined below: a. Prior systemic chemotherapy must include a line of chemoimmunotherapy that includes an anti-CD20 antibody, an anthracycline, and 1 or more of the following: i. No response to first-line therapy (primary refractory disease). Refractory disease (defined as SD, PD, PR or CR with relapse before 3 months). ii. Progressive disease following two or more lines of therapy. However, SD as the best response after at least 2 cycles of the last line of