RecruitingPhase 1Phase 2NCT05326243

Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma

A Phase 1/2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma

Sponsor

Pell Bio-Med Technology Co., Ltd.

Enrollment

49 participants

Start Date

May 31, 2022

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma Large B-cell Lymphoma Primary Mediastinal Large B Cell Lymphoma Follicular Lymphoma Grade 3B Follicular Lymphoma Grade 3A

Summary

This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).

Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1/2 study tests a CAR-T cell therapy targeting the CD19 protein on cancerous B-cells in patients with relapsed or refractory B-cell lymphoma or leukemia, to see if these engineered immune cells can put the cancer into remission. **You may be eligible if...** - You have relapsed or refractory B-cell lymphoma or B-cell acute lymphoblastic leukemia (B-ALL) - Your cancer cells express the CD19 protein - You have received prior standard treatments that have not worked - You are 18 or older (or pediatric depending on protocol) - You have adequate organ function **You may NOT be eligible if...** - You have active brain involvement by lymphoma/leukemia (in some protocols) - You have an active severe autoimmune disease - You are pregnant or breastfeeding - You have uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD19-targeted chimeric antigen receptor T-cell

Drug: Fludarabine patients will receive a lymphodepletion chemotherapy with Fludarabine 25 mg/m2/day IV for 3 days on Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3). Drug: Cyclophosphamide patients will receive a lymphodepletion chemotherapy with cyclophosphamide 300 mg/m2/day IV for 3 dys Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3). Biological: CD19 CAR-T CD19 CAR-T cells will be administered using as a single dose at 0.1-9\*10\^6 cells/kg on Day 0 after completion of the lymphodepletion chemotherapy. The body weight calculated for PL001 dose is the actual body weight on the day of leukapheresis.