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

NCT07587125 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: KY20262101JIANGWEN
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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; Refractory Multiple Sclerosis; Multiple Sclerosis (MS) Primary Progressive; Multiple Sclerosis (MS) Secondary Progressive

Keywords

Multiple Sclerosis; Progressive Multiple Sclerosis; Refractory Multiple Sclerosis; BCMA-CAR T Cells; Chimeric Antigen Receptor T-Cell Therapy; Safety and Efficacy

Outcome Measures

Primary Outcomes (2)

• Incidence and type of Dose-Limiting Toxicities (DLTs)

  A DLTs is defined as any Grade 4 toxicity or Grade 3 toxicity lasting more than 7 days occurring within 28 days after BCMA-CAR T infusion that is related to the treatment (with specific exceptions for manageable CRS, neurotoxicity, and hematologic toxicities as defined in the protocol). This is used to determine the safety and tolerable dose.

  From Day 1 up to Day 28 post S103 infusion

• Incidence and severity of AEs, including changes in vital signs, physical examination, laboratory parameters, Electrocardiograms and Echocardiograms.

  To evaluate the AEs occurring within 6 months after S103 infusion

  From Day 1 up to week 26 post S103 infusion

Secondary Outcomes (5)

• PD-soluble BCMA

  From Day 1 up to week 26 post S103 infusion

• PK-BCMA CAR-T cells

  From Day 1 up to Day 28 post S103 infusion

• PD-NFL

  From Day 1 up to week 26 post S103 infusion

• PD-OB

  From Day 1 up to week 26 post S103 infusion

• Changes of Expanded Disability Status Scale（EDSS）scores

  From Day 1 up to week 26 post S103 infusion

Other Outcomes (10)

• Changes in proportion of peripheral blood immune cell subsets and inflammatory markers levels

  From Day 1 up to week 26 post S103 infusion

• Changes in Cerebrospinal Fluid (CSF) parameters

  From Day 1 up to week 26 post S103 infusion

• MS: Annualized Relapse Rate (ARR)

  From Day 1 up to 1 year post S103 infusion

Study Arms (1)

S103 cells

EXPERIMENTAL

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

Drug: S103 cells

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

S103 cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and ≤75 years;
• The subject signs the informed consent form, is willing and able to comply with the protocol, complete the research assessments and return for follow-up;
• To be diagnosed with Multiple Sclerosis (MS) according to the 2017 McDonald criteria, specifically including Progressive MS (Primary Progressive MS \[PPMS\] or Secondary Progressive MS \[SPMS\]) or Relapsing-Remitting MS (RRMS);
• The subject must be assessed by the investigator as having progressive or refractory MS for which no effective standard therapy is available. For subjects with Relapsing MS (RMS), refractory/progressive disease is defined as having experienced at least 2 clinical relapses within the past 2 years, or at least 1 clinical relapse within the past 1 year accompanied by at least one gadolinium-enhancing lesion on MRI within the past year, despite treatment with standard disease-modifying therapies (DMTs). In addition, the subject must have an Expanded Disability Status Scale (EDSS) score between 2.0 and 7.0, inclusive, at both screening and baseline;
• Male study participants must agree to take contraceptive measures during the treatment period and within 1 year after receiving study treatment, and are prohibited from donating sperm throughout the study period;
• Women of childbearing potential (WOCBP) must agree to take contraceptive measures during treatment and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result during screening; a negative urine pregnancy test result must be confirmed before receiving CAR-T for the first time.

You may not qualify if:

• The subject has any medical, psychological, or social condition that, in the investigator's opinion, may harm the subject, interfere with their ability to participate in the study, or result in poor protocol compliance;
• Female subjects who are pregnant or lactating, plans to become pregnant at any time within 12 months after receiving CAR-T cell treatment, or has a history of spontaneous or induced abortion within 4 weeks prior to screening;
• The subject has a clinically relevant active infection, such as sepsis, pneumonia, or a severe local abscess, or a serious infection requiring hospitalization or intravenous antibiotic treatment within 4 weeks prior to screening. Subjects are also excluded if they have a known immunodeficiency disorder including Human Immunodeficiency Virus (HIV), test positive for Hepatitis B surface antigen (HBsAg) or detectable Hepatitis B virus (HBV) DNA, test positive for Hepatitis C virus (HCV) antibody with detectable HCV RNA, test positive for syphilis during the screening period, or have an active or high-risk history of tuberculosis infection;
• The subject has previously received any Chimeric Antigen Receptor (CAR) T-cell therapy or other genetically modified cell therapies, or has a history of allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Furthermore, subjects are excluded if they have received intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 4 weeks prior to screening, or have received tocilizumab or eculizumab treatment within 3 months prior to screening;
• The subject is diagnosed with an active, severe autoimmune disease other than Multiple Sclerosis, such as Systemic Lupus Erythematosus or Rheumatoid Arthritis. This also includes the presence of other severe progressive neurodegenerative or central nervous system (CNS) disorders, such as Parkinson's disease, Alzheimer's disease, stroke, or active CNS tumors, that the investigator believes would confound the clinical assessment of Multiple Sclerosis. Additionally, a history of active malignancy within the past 5 years excludes the subject, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;
• The subject has a known severe allergy, hypersensitivity, or intolerance to fludarabine, cyclophosphamide, or any excipients contained in the S103 CAR-T cell product, such as human serum albumin. Subjects are also excluded if they have received any live attenuated vaccine within 6 weeks prior to screening, or plan to receive a live vaccine during the study period.

Sponsors & Collaborators

• Xijing Hospital: lead
• Hebei Senlang Biotechnology Co., LTD: collaborator

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wen Jiang Dr.

CONTACT

86 29 84771319; jiangwen@fmmu.edu.cn

Xiaodan Shi Dr.

CONTACT

+86 29 84771319; Shixd999@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-04

Locations

CN (1)