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RECRUITING
NCT06414135
PHASE1

Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis

Sponsor: Liangjing Lu

View on ClinicalTrials.gov

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.

Official title: A Dose Ranging Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Relmacabtagene Autoleucel (Relma-cel) in Patients With Refractory/Progressive Systemic Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-06-12

Completion Date

2027-04

Last Updated

2024-08-15

Healthy Volunteers

No

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

Locations (1)

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China