NCT06227026 Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies

Trial Parameters

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Brief Summary

This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.

Eligibility Criteria

Inclusion Criteria: * Subjects aged ≥ 18 years. * Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)/Richter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis. * Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy. * ECOG Performance Status ≤ 2. * Life expectancy \> 12 weeks. * Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation * Adequate organ function as defined as: * Hematologic: * Absolute neutrophil count (ANC) ≥ 500/mm3 * Platelet count ≥ 10,000/mm3 * Hemoglobin ≥ 8 g/dL * Hepatic: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN). * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN * Renal: * Serum Creatinine ≤ 2 x institutional upper limit of norma

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