UCAR T-cell Therapy Targeting CD19/ BCMA(QT-019C) 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(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases

Status

Withdrawn

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07410377

Enrollment

Registered

2026-02-13

Start date

2026-03-01

Completion date

2028-09-01

Last updated

2026-05-28

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

Conditions

Inflammatory Myopathy, Systemic Lupus Erythematosus

Brief summary

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in With Relapse/Refractory Autoimmune Diseases.

Detailed description

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases. Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.

Interventions

BIOLOGICALUCAR-T cells

QT-019C will be administered intravenously as per the schedule specified in the protocol.

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. Adequate hepatic, renal and bone marrow function.3 Participants with relapsed or refractory autoimmune diseases, Including SLE or IM.

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
The number and severity of dose-limiting toxicity (DLT) events	Within 28 Days After QT-019C infusion	DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
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 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: May 29, 2026