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A single-center, open-arm, single-arm clinical study for the safety and efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases

A single-center, open-arm, single-arm clinical study for the safety and efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023139
Enrollment
Unknown
Registered
2019-05-13
Start date
2019-05-13
Completion date
Unknown
Last updated
2019-05-20

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

Conditions

autoimmune diseases

Interventions

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 10-70 years; 2. Expected survival beyond 12 weeks; 3. Patients with autoimmune diseases diagnosed by physical examination, pathological examination, laboratory examination and imaging. The curative effect of conventional treatment is poor, and there is no effective treatment. 4. Creatinine 50; 8. Patients can understand and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected or active hepatitis B or hepatitis C infection; 3. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 4. Patients with abnormal vital signs or could not cooperate with inspectors; 5. History of mental disorders; 6. Highly allergic constitution or severe allergies, especially allergic to IL-2; 7. Systemic infection or serious infections should be local anti-infection treatment; 8. With heart, lung, brain, liver, kidney and other important organ dysfunction; 9. Other situations we think improper for the research.

Design outcomes

Primary

MeasureTime frame
Degree of antibody;Index of disease activity;The degree of improvement of clinical symptoms;Safety;

Countries

China

Contacts

Public ContactKailin Xu

The Affiliated Hospital of Xuzhou Medical University

lihmd@163.com+86 0516 85806982

Outcome results

None listed

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