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CD19/BCMA CAR-T for SLE

NCT07266337 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-05

No results posted yet for this study

Summary

The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product.

The main questions it aims to answer are:

1. What CAR-T-related adverse events (AEs) occur within 3 months after the CAR-T cell infusion?
2. Which dose level is the optimal biological dose (OBD)?
3. What is the the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?

Participants will:

1. Receive CD19/BCMA CAR-T cells infusion on Day 0.
2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
3. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after CAR-T cells infusion.

Conditions

  • SLE - Systemic Lupus Erythematosus

Interventions

DRUG

CD19/BCMA CAR T-cells

intravenous injection of CD19/BCMA CAR-T cells

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    collaborator OTHER

  • Chengdu Ucello Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tao Wang, M.D. · The General Hospital of Western Theater Command

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-10
Primary Completion
2035-12-31
Completion
2037-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266337 on ClinicalTrials.gov