UCAR T-cell Therapy Targeting CD19/ BCMA(QT-019C) in Patients With Relapse/ Refractory Autoimmune Diseases

Xuzhou Medical University

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Inflammatory Myopathy

Systemic Lupus Erythematosus

Treatments

Biological: UCAR-T cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07410377

QH-XZ-03

Details and patient eligibility

About

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in With Relapse/Refractory Autoimmune Diseases.

Full description

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases.

Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old (inclusive), regardless of gender. 2. Adequate hepatic, renal and bone marrow function.3 Participants with relapsed or refractory autoimmune diseases, Including SLE or IM.

Exclusion criteria

1. Participants 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. Participants with insufficient cardiac function.4. Participants with congenital immunoglobulin deficiencies.5. History of malignancy within five years.