Study Summary
The objective of this Phase I clinical trial is to evaluate the safety, toxicity profile, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of autologous CAR-T anti-CD19 cell therapy (CAR-T ANTI-CD19 COL01) in adult participants (aged 18 years and older) with relapsed or refractory CD19-positive B-cell lymphoid malignancies (including diffuse large B-cell lymphoma \[DLBCL\], mantle cell lymphoma \[MCL\], follicular lymphoma \[FL\], and precursor B-cell acute lymphoblastic leukemia \[B-ALL\]) after at least two prior lines of systemic treatment. The primary questions this study aims to answer are: What is the safety and toxicity profile, including the incidence and severity of adverse events (such as Cytokine Release Syndrome \[CRS\], Immune Effector Cell-Associated Neurotoxicity Syndrome \[ICANS\]), and dose-limiting toxicities (DLTs) associated with CAR-T ANTI-CD19 COL01? What is the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CAR-T ANTI-CD19 COL01 for future clinical studies? Comparison Group: This is a single-arm, non-comparative Phase I study; there is no comparison or control group. All enrolled participants receive the investigational CAR-T ANTI-CD19 COL01 therapy. Participants will be asked to: Undergo screening procedures and baseline diagnostic assessments to determine eligibility. Undergo leukapheresis for peripheral blood T-cell collection to manufacture the autologous CAR-T cell product. Receive a lymphodepleting conditioning chemotherapy regimen prior to product administration. Receive a single intravenous infusion of CAR-T ANTI-CD19 COL01 cells. Complete mandatory post-infusion monitoring (inpatient and outpatient surveillance), safety checks, blood sampling, and clinical disease response evaluations (including imaging and/or bone marrow examinations).
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