CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.

Eligibility criteria

Qualifiers

Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.

Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).

Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR < 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)

Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.

Disqualifiers

1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.

Trial design

Treatments tested in this trial

  • UCAR T-cell

Treatment groups

15 Participants
are divided into 1 treatment group