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

NCT07152223 | Withdrawn

• 1 other identifier: CF-25-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Connective Tissue Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety

  Count the Incidence of adverse events

  Up to 2 years after CAR-T infusion

Secondary Outcomes (3)

• Effectiveness evaluation

  Up to 2 years after CAR-T infusion

• Pharmacokinetic parameters

  Up to 2 years after CAR-T infusion

• Pharmacodynamic parameters

  Up to 2 years after CAR-T infusion

Study Arms (1)

CAR-T

EXPERIMENTAL

The dosage range of 1.0 × 10\^6/kg (± 20%) to 3.0 × 10\^6/kg (± 20%) of CAR-T cells, administered intravenously.

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

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

CAR-T

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Good compliance: The patient or their guardian understands and voluntarily signs the informed consent form, and it is expected that all documents, procedures, follow-up examinations and treatments stipulated in the study can be completed.
• Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria :
• Systemic lupus erythematosus (SLE);
• Rheumatoid arthritis (RA);
• Systemic scleroderma (SSc) ;
• Sjogren's Syndrome (SS);
• Polymyositis/dermatomyositis (PM/DM);
• Mixed connective tissue disease (MCTD).
• Researchers determine that the disease is in an active stage;
• At least one autoantibody is positive in the serum or plasma during the screening period;
• Insufficient response, intolerance or recurrence to at least one standard treatment;
• The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period.
• The patient's major tissues and organs are functioning well.

You may not qualify if:

• Intracranial hypertension or confusion;
• Symptomatic heart failure or severe arrhythmia;
• Respiratory failure;
• Accompanied by other types of malignant tumors;
• Diffuse vascular coagulation;
• Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
• Sepsis or other difficult-to-control infections;
• Uncontrollable diabetes;
• Severe mental disorder;
• Cranial magnetic resonance imaging (MRI) examination revealed obvious lesions in the intracranial cavity.
• WHO physical status classification ≥ level 3;
• Organ transplant recipients;
• Pregnant and lactating women;
• HIV+，HBV，HCV，EBV，CMV.

Sponsors & Collaborators

• Guangzhou Bio-gene Technology Co., Ltd: lead

Study Sites (1)

Dongguan Taixin Hospital

Dongguan, Guangdong, 523125, China

Location

MeSH Terms

Conditions

Connective Tissue Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Yuelin He, Ph.D. degree

  Dongguan Taixin Hospital

  PRINCIPAL INVESTIGATOR

• Lan He, Ph.D. degree

  Dongguan Taixin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 7, 2025
• Primary Completion: March 2, 2026
• Study Completion: March 2, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)