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A clinical study on the safety and effectiveness of Dual BCMA-CD19 CAR-T treatment of autoimmune diseases

A clinical study on the safety and effectiveness of Dual BCMA-CD19 CAR-T treatment of autoimmune diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052400
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

autoimmune diseases

Interventions

Case series:CAR-NK cells

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Chinese subjects aged 18 to 70 years when signing the informed consent; 2. Expected survival > 12 weeks; 3. Diagnosed with autoimmune disease by physical examination, pathological examination, laboratory examination and imaging, and the therapeutic effect of glucocorticoid and/or immunosuppressive agent is not good; 4. Creatinine < 2.5mg/dl; 5. ALT, AST < 3 times ULN; 6. Bilirubin < 2.0mg/dl; 7. ECOG score 0~1; 8. The patient's peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9. Subjects must obtain informed and signed informed consent, indicating that they understand the purpose and procedures of this study and are willing to participate in the study; willing and able to follow the contraindications and restrictions specified in this protocol.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant (positive blood pregnancy test) or breastfeeding, or women who plan to become pregnant within one year; 2. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 3. The patient has participated in other clinical trials before enrollment and has not passed the washout period; 4. Those with abnormal vital signs and those who cannot cooperate with the inspection; 5. Highly allergic or have a history of severe allergies, especially those allergic to IL-2; 6. Suffering from serious mental illness; 7. The patient has drug abuse/addiction; 8. Subjects with systemic infection or severe local infection requiring anti-infection treatment; 9. Complicated with dysfunction of important organs such as heart, lung, brain, liver and kidney; 10. According to the judgment of the investigator, the patient has other conditions that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Safety;efficacy;Progression Free Survival;

Countries

China

Contacts

Public ContactCao Jiang

The Affiliated Hospital of Xuzhou Medical University

zimu05067@163.com+86 0516 85805151

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026