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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
ChiCTR2200061267
Enrollment
Unknown
Registered
2022-06-18
Start date
2022-06-05
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

autoimmune diseases

Interventions

Group 1 :CAR-T cells

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Chinese subjects aged >= 5 years old and 12 weeks; 3. The autoimmune disease is diagnosed by physical examination, pathological examination, laboratory examination and imaging, and the effect of conventional treatment is not good, and there is no effective treatment; 4. Creatinine < 2.5 mg/dl; 5. ALT, AST < 3 times ULN; 6. Bilirubin < 2.0 mg/dl; 7. ECOG score 0-1; 8. The peripheral superficial venous blood flow of the patient is smooth, which can meet the needs of intravenous infusion; 9. Subjects/legal guardians must obtain and sign an informed consent form, indicating that they understand the purpose and procedures of this study and are willing to participate in the study; they are 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 have a pregnancy plan within one year; 2. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 3. Patients have participated in other clinical trials before enrollment and have not passed the washout period; 4. The vital signs are abnormal, and those who cannot cooperate with the examination; 5. Highly allergic constitution or 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 local severe infection requiring anti-infection treatment; 9. Combined with dysfunction of heart, lung, brain, liver, kidney and other important organs; 10. According to the investigator's judgment, the patient has other conditions that are not suitable for enrollment.

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+86 516 85805151

Outcome results

None listed

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