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Safety and Efficacy of S103 Cells in Progressive/Refractory Multiple Sclerosis

NCT07587125 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-14

No results posted yet for this study

Summary

This study is a single-center, open-label, single-arm, exploratory clinical study to evaluate the safety, tolerability, and preliminary efficacy of S103（BCMA-CAR T ）cells in the treatment of progressive or refractory multiple sclerosis. The study is a dose escalation trial in adult progressive and refractory MS patients. A standard "3+3" design will be used to perform dose escalation to explore the safety profile and dose-limiting toxicities (DLTs). A total of 9 MS patients who meet the inclusion criteria are expected to be recruited.

Conditions

  • Multiple Sclerosis (MS) Primary Progressive
  • Multiple Sclerosis
  • Multiple Sclerosis (MS) Secondary Progressive
  • Refractory Multiple Sclerosis

Interventions

DRUG

S103 cells

Dose Level 0 (De-escalation dose): 0.5×10\^6 CAR-T cells/kg Dose Level 1 (Starting dose): 1.0×10\^6 CAR-T cells/kg Dose Level 2 (Maximum dose): 2.0×10\^6 CAR-T cells/kg

Sponsors & Collaborators

  • Hebei Senlang Biotechnology Co., LTD

    collaborator UNKNOWN

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-11-30
Completion
2029-11-30

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 NCT07587125 on ClinicalTrials.gov