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

Sponsor
Xijing Hospital
Study ID
NCT07587125
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • S103 cells — DRUG
    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

Study Details

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.

Key Dates

First listed
May 14, 2026
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: S103 cells
    subjects will undergo leukapheresis followed by lymphodepletion conditioning with cyclophosphamide and fludarabine, then receive S103 CAR-T cell infusion.

Primary Outcome Measure

Incidence and type of Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 1 up to Day 28 post S103 infusion ]

Central Contacts

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