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

NCT07410377 | Not Yet Recruiting Early Phase 1

• 1 other identifier: QH-XZ-03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Inflammatory Myopathy

Outcome Measures

Primary Outcomes (3)

• The number and severity of dose-limiting toxicity (DLT) events

  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.

  Within 28 Days After QT-019C infusion

• 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 (1)

• 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（QT-019C） Drug: Cyclophosphamide

Biological: UCAR-T cells

Interventions

UCAR-T cells BIOLOGICAL

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

UCAR T-cell group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead
• Shanghai Xiniao Biotech Co., Ltd.: collaborator

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myositis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Dongmei Zhou

CONTACT

+86180 5226 8809; 13813283017@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)