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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus Systemic Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCAR T-cell group

Participants will receive the following interventions and dose escalated per protocol:

Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine

Group Type EXPERIMENTAL

UCAR-T cells

Intervention Type BIOLOGICAL

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

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide will be administered intravenously.

Fludarabine

Intervention Type DRUG

Fludarabine will be administered intravenously.

Interventions

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UCAR-T cells

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

Intervention Type BIOLOGICAL

Cyclophosphamide

Cyclophosphamide will be administered intravenously.

Intervention Type DRUG

Fludarabine

Fludarabine will be administered intravenously.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No