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

Xuzhou Medical University

Status: Active, not recruiting

Conditions: Systemic Sclerosis; Systemic Lupus Erythematosus

Treatments: Biological: UCAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07155369

QH-XZ-02

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 in With Relapse/Refractory Autoimmune Diseases.

Full description

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

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

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old (inclusive), regardless of gender.
2. Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
3. Adequate hepatic, renal and bone marrow function.
4. Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

UCAR T-cell group

Experimental group

Description:

Participants will receive the following interventions and dose escalated per protocol: Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine

Treatment:

Drug: Cyclophosphamide

Drug: Fludarabine

Biological: UCAR-T cells