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CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus

NCT05765006 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-03-15

No results posted yet for this study

Summary

This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.

Conditions

Interventions

BIOLOGICAL

Relma-cel

CD19-targeted Chimeric AntigenReceptor (CAR) T Cells; Relma-cel be administrated at four dose level:25×106 CAR+ T cells、50×106 CAR+ T cells、100×106 CAR+ T cells/150×106 CAR+ T cells

Sponsors & Collaborators

  • Shanghai Ming Ju Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • yu Hu · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • heng Mei · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • liangjing Lv · Renji Hospital Shanghai Jiaotong University School of Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-24
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05765006 on ClinicalTrials.gov