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

Phase 1/2 Recruiting 49 enrolled Pell Bio-Med Technology Co., Ltd.

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2022-05-31
Primary completion: 2026-12-31
Completion: 2027-03-31

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PL001	Cell therapy	—	—
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous

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

Summary

Timeline

Drugs

Indications