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Clinical Study on the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases

NCT07152223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-03

No results posted yet for this study

Summary

This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.

Conditions

  • Connective Tissue Diseases

Interventions

BIOLOGICAL

CAR-T

Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.

Sponsors & Collaborators

  • Guangzhou Bio-gene Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yuelin He, Ph.D. degree · Dongguan Taixin Hospital

  • Lan He, Ph.D. degree · Dongguan Taixin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2029-08-31
Completion
2029-08-31

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 NCT07152223 on ClinicalTrials.gov