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

A Single-center Clinical Study to Evaluate the Safety and Efficacy of CD19-BCMA CAR-T Cell Therapy for Connective Tissue Diseases

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07152223

Enrollment

Registered

2025-09-03

Start date

2025-08-07

Completion date

2026-03-02

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Diseases

Keywords

Connective Tissue Diseases

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.

Interventions

BIOLOGICALCAR-T

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. 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. 2. Previously diagnosed with one of the following diseases and meeting the corresponding latest international classification/diagnostic criteria : 1. Systemic lupus erythematosus (SLE); 2. Rheumatoid arthritis (RA); 3. Systemic scleroderma (SSc) ; 4. Sjogren's Syndrome (SS); 5. Polymyositis/dermatomyositis (PM/DM); 6. Mixed connective tissue disease (MCTD). 3. Researchers determine that the disease is in an active stage; 4. At least one autoantibody is positive in the serum or plasma during the screening period; 5. Insufficient response, intolerance or recurrence to at least one standard treatment; 6. The pregnancy test of the female subjects was negative, and the subjects agreed to take effective contraceptive measures throughout the trial period. 7. The patient's major tissues and organs are functioning well.

Exclusion criteria

1. Intracranial hypertension or confusion; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. Accompanied by other types of malignant tumors; 5. Diffuse vascular coagulation; 6. Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; 7. Sepsis or other difficult-to-control infections; 8. Uncontrollable diabetes; 9. Severe mental disorder; 10. Cranial magnetic resonance imaging (MRI) examination revealed obvious lesions in the intracranial cavity. 11. WHO physical status classification ≥ level 3; 12. Organ transplant recipients; 13. Pregnant and lactating women; 14. HIV+，HBV，HCV，EBV，CMV.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of Safety	Up to 2 years after CAR-T infusion	Count the Incidence of adverse events

Secondary

Measure	Time frame	Description
Effectiveness evaluation	Up to 2 years after CAR-T infusion	The response rate of the responder index of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (scleroderma SSc), Sjogren's Syndrome, polymyositis/dermatomyositis, and mixed connective tissue disease (MCTD), as well as the changes in scores compared with the baseline value
Pharmacokinetic parameters	Up to 2 years after CAR-T infusion	The highest concentration of CAR-T cell expansion in peripheral blood after administration.
Pharmacodynamic parameters	Up to 2 years after CAR-T infusion	The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.

Countries

China

Contacts

PRINCIPAL_INVESTIGATORYuelin He, Ph.D. degree

Dongguan Taixin Hospital

PRINCIPAL_INVESTIGATORLan He, Ph.D. degree