NCT06911710

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, single-arm, prospective, Phase I/II clinical study using "3+3" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed/refractory malignant hematological neoplasms in subjects.

Conditions

• Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)
• AML (Acute Myelogenous Leukemia)
• Myeloma Multiple
• B-ALL
• T-ALL/Lymphoma
• T-lymphocyte Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-09
• Primary completion: 2026-02-28
• Completion: 2027-02-28
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: China