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
Guangzhou Bio-gene Technology Co., Ltd
20 participants
Aug 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- 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.
Exclusion Criteria14
- 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.
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Interventions
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07152223