Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07155369

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Participants with a history of severe drug allergies or allergic constitutions.
  • Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
  • Participants with insufficient cardiac function.
  • Participants with congenital immunoglobulin deficiencies.
  • History of malignancy within five years.

Treatment and study plan

UCAR-T cells

Biological

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

Cyclophosphamide

Drug

Cyclophosphamide will be administered intravenously.

Fludarabine

Drug

Fludarabine will be administered intravenously.

Primary outcomes

  1. To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases

    Time frame: 2 years

    The incidence and severity of adverse events (AEs)

  2. To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases

    Time frame: 2 years

    Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline

Secondary outcomes

  1. To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases

    Time frame: 2 years

    AUC0-28d

  2. To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases

    Time frame: 2 years

    Cmax

  3. To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases

    Time frame: 2 years

    Tmax

  4. To characterize pharmacodynamics of of UCAR-T cells in participants.

    Time frame: 2 years

    Changes in B-cell levels in the peripheral blood from baseline.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Collaborators

  • Shanghai Xiniao Biotech Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.