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

NCT07756268 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-08-10

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • CSPC Baike (Shandong) Bio-Pharmaceutical Co., Ltd.

    collaborator UNKNOWN

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Chuan Qin, MD · Tongji Hospital

  • Daishi Tian, MD · Tongji Hospital

  • Zhouping Tang, MD · Tongji 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
2026-09-16
Primary Completion
2029-02-07
Completion
2029-02-07

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 NCT07756268 on ClinicalTrials.gov