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Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis

NCT06414135 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-08-15

No results posted yet for this study

Summary

Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.

Conditions

Interventions

BIOLOGICAL

Relma-cel

All participants will receive Relma-cel once at different dose levels: 25×10\^6 CAR+ T cells、50×10\^6 CAR+ T cells、75×10\^6 CAR+ T cells

Sponsors & Collaborators

  • Shanghai Ming Ju Biotechnology Co., Ltd.

    collaborator INDUSTRY

  • Liangjing Lu

    lead OTHER

Principal Investigators

  • Liangjing Lu · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2025-05-31
Completion
2027-04-30

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 NCT06414135 on ClinicalTrials.gov