UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChangzhou No.2 People's Hospital

About this trial

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Eligibility criteria

Qualifiers

1.Age ≥ 18 years old (inclusive), regardless of gender.

2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.

Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 ^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 ^ 9/L.

Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);

Disqualifiers

1.Subjects with a history of severe drug allergies or allergic constitutions;

2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;

3. Subjects with insufficient cardiac function;

4. Subjects with congenital immunoglobulin deficiencies;

Trial design

Treatments tested in this trial

  • universal allogeneic anti-CD19/BCMA CAR T-cells

Treatment groups

18 Participants
are divided into 1 treatment group