NCT07155369

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
27mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Mar 2025Sep 2028

Study Start

First participant enrolled

March 18, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

1.5 years

First QC Date

August 20, 2025

Last Update Submit

September 1, 2025

Conditions

Systemic Lupus ErythematosusSystemic Sclerosis

Outcome Measures

Primary Outcomes (2)

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

    The incidence and severity of adverse events (AEs)

    2 years

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

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

    2 years

Secondary Outcomes (4)

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

    2 years

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

    2 years

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

    2 years

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

    2 years

Study Arms (1)

UCAR T-cell group

EXPERIMENTAL

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

Biological: UCAR-T cellsDrug: CyclophosphamideDrug: Fludarabine

Interventions

UCAR-T cellsBIOLOGICAL

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

UCAR T-cell group
CyclophosphamideDRUG

Cyclophosphamide will be administered intravenously.

UCAR T-cell group
FludarabineDRUG

Fludarabine will be administered intravenously.

UCAR T-cell group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicScleroderma, Systemic

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 4, 2025

Study Start

March 18, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

September 4, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)