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

NCT06911710 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-04-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Hebei Taihe Chunyu Biotechnology Co., Ltd

    collaborator INDUSTRY

  • Tianjin Medical University General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-09
Primary Completion
2026-02-28
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911710 on ClinicalTrials.gov