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

A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07155369

Enrollment

Registered

2025-09-04

Start date

2025-03-18

Completion date

2028-09-30

Last updated

2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus, Systemic Sclerosis

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.

Interventions

BIOLOGICALUCAR-T cells

UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.

DRUGCyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUGFludarabine

Fludarabine will be administered intravenously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases	2 years	AUC0-28d
To characterize pharmacodynamics of of UCAR-T cells in participants.	2 years	Changes in B-cell levels in the peripheral blood from baseline.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026