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NOT YET RECRUITING
NCT07756268
PHASE1/PHASE2

Phase Ib/II Study of SYS6020 in Relapsing/Refractory Multiple Sclerosis

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This trial is an investigator-initiated, single-arm, open-label Phase Ib/II study to observe the safety, tolerability, PK/PD characteristics, immunogenicity, and the efficacy of SYS6020 injection in participants with relapsed/refractory multiple sclerosis. The study plans to enroll participants with progressive or relapsing multiple sclerosis. The recommended dosing regimen is as follows: a single administration dose of 45×10\^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses. To ensure participant safety, this study will establish a Safety Monitoring Committee (SMC). A staggered enrollment and dosing strategy will be adopted in the early stage. Two early safety evaluation will be established (after the first 3 enrolled participants complete their first 3 infusions of SYS6020, and after the first 3 enrolled participants complete their first 6 infusions of SYS6020) for comprehensive assessment. The study plans to enroll 10-15 participants. Once the enrollment of 10-15 participants is complete, a comprehensive assessment may be conducted based on the actual progress of the study and combined with existing data. This will fully evaluate the safety, preliminary efficacy, and PK/PD/ADA data of the enrolled participants. If the overall safety of the participants is manageable, preliminary efficacy shows a positive trend, and there are value and necessity for further exploration, expanding the number of participants may be considered (up to a maximum of 25 participants in total).

Official title: A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6020 Injection in Patients With Relapsing/Refractory Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-09-16

Completion Date

2029-02-07

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

SYS6020 injection

SYS6020 injection is an injection of autologous CAR-T cells that have been temporarily transfected with LNP-mRNA targeting BCMA. The eligible participants will receive a single administration dose of 45×10\^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses

Locations (1)

Tongji Hospital, Tongji Medical College of Hust

Wuhan, Hubei, China