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

Not Applicable

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus; Systemic Sclerosis
• Interventions: Biological: UCAR-T cells; Drug: Cyclophosphamide; Drug: Fludarabine

• Registration Number: NCT07155369
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2025-03-18
• Study First Submitted: 2025-08-20
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2026-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases	2 years	The incidence and severity of adverse events (AEs)
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases	2 years	Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline

Secondary Outcome Measures

Name	Time	Method
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases	2 years	Tmax
To characterize pharmacodynamics of of UCAR-T cells in participants.	2 years	Changes in B-cell levels in the peripheral blood from baseline.

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, China