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Clinical Trials in China / NCT07155369
Active, not recruiting Not applicable

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

NCT07155369 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Phase
Not applicable
Started
2025-03-18
Last updated
2025-09-04

Condition(s) studied

Systemic Lupus ErythematosusSystemic Sclerosis

Investigational drug(s) / intervention(s)

UCAR-T cellsCyclophosphamide →Fludarabine →

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

Cyclophosphamide: Cyclophosphamide will be administered intravenously.

Fludarabine: Fludarabine will be administered intravenously.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
The Affiliated Hospital of Xuzhou Medical University Xuzhou China

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Other trials for the same condition

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus Recruiting
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases Starting soon
Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus Active, not recruiting
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07155369 on ClinicalTrials.gov ↗ ← All trials in China