The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 9, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)AML (Acute Myelogenous Leukemia)Myeloma MultipleB-ALLT-ALL/LymphomaT-lymphocyte Lymphoma
Interventions
DRUG

CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc)

"Phase I study: dose-escalation component.This part follows the 3+3 dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection."

Trial Locations (1)

300072

RECRUITING

TianJin China. TianJin Medical University General, Tianjin

All Listed Sponsors
collaborator

Hebei Taihe Chunyu Biotechnology Co., Ltd

INDUSTRY

lead

Tianjin Medical University General Hospital

OTHER