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

Starting soon · Phase 1/Phase 2

Conditions studied: Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT07756268

Run by

Tongji Hospital

People needed

25

Starts

2026-09-16

Expected to finish

2029-02-07

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Male or female participants aged 18-65 years at the time of signing informed consent.
• Diagnosis of progressive multiple sclerosis (primary progressive MS [PPMS] or secondary progressive MS [SPMS]) or relapsing multiple sclerosis (RMS) according to the 2024 McDonald criteria.
• Inadequate response to at least one disease-modifying therapy (DMT) administered for ≥6 months:
• For progressive MS: evidence of worsening disability, such as an increased Expanded Disability Status Scale (EDSS) score.
• For RMS: at least one of the following:
• i. ≥2 relapses within 2 years before screening; ii. ≥1 relapse within 1 year before screening; or iii. Gadolinium-enhancing lesions on MRI within 1 year before screening. 4. Positive cerebrospinal fluid oligoclonal bands or an elevated immunoglobulin G index, documented previously or during screening.
• Typical MS lesions on brain and/or spinal cord MRI, documented previously or during screening.
• Screening EDSS score of 3.0-7.0. 7. Adequate baseline organ function, including:
• Absolute lymphocyte count ≥0.3 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L, and hemoglobin ≥80 g/L, without red blood cell or platelet transfusion or colony-stimulating factor within 7 days before testing;
• Total bilirubin ≤2 × upper limit of normal (ULN), and alanine aminotransferase and aspartate aminotransferase ≤3 × ULN;
• Serum creatinine ≤1.5 × ULN and creatinine clearance ≥40 mL/min by the Cockcroft-Gault formula;
• Activated partial thromboplastin time and international normalized ratio ≤1.5 × ULN;
• Oxygen saturation ≥90% on room air;
• Serum potassium ≥3.0 mmol/L and calcium ≥2.0 mmol/L. 8. Participants of reproductive potential must use reliable contraception during the study and for at least 2 years after the last SYS6020 infusion. Women must not donate oocytes and men must not donate sperm for assisted reproduction during this period. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test before leukapheresis.

You may not qualify if…

• 1. Uncontrolled significant chronic disease that, in the investigator's opinion, may increase the participant's risk.
• Another autoimmune disease requiring systemic treatment, except adequately treated autoimmune thyroid disease with stable treatment and normal thyroid function.
• History of primary immunodeficiency, organ transplantation, or hematopoietic stem cell/bone marrow transplantation, or planned transplantation during the study.
• Current psychotic disorder. 5. Suicidal ideation within 6 months before informed consent, suicidal behavior within 12 months before informed consent, or a significant suicide risk in the investigator's opinion.
• Alcohol or drug abuse/dependence likely to impair study compliance. 7. Stroke, transient ischemic attack, or another active central nervous system disorder unrelated to neuroimmunological disease within 6 months before enrollment.
• Significant cardiovascular disease, including:
• Clinically significant ventricular arrhythmia, second- or third-degree atrioventricular block, or another serious rhythm/conduction disorder;
• Resting QT interval corrected using Fridericia's formula >450 msec for men or >470 msec for women;
• Acute coronary syndrome, congestive heart failure, or another Grade ≥3 cardiovascular event within 6 months before first administration;
• Left ventricular ejection fraction <50%;
• Risk factors for QT prolongation or arrhythmia, including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of QT-prolonging medications;
• Poorly controlled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
• Major surgery or invasive intervention within 4 weeks before leukapheresis, or planned systemic or local tumor resection during the study.
• Grade ≥2 bleeding within 30 days before screening or a need for continuous long-term anticoagulant therapy.
• Active malignancy or history of malignancy, except:
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• Curatively treated basal cell carcinoma, localized cutaneous squamous cell carcinoma, or cervical carcinoma in situ completed >12 months before screening; or
• Other malignancies with curative treatment completed ≥5 years before screening. 12. Severe recurrent infections or any active infection that may interfere with study participation.
• Any of the following viral hepatitis findings:
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• Positive hepatitis B surface antigen;
• Positive hepatitis B core antibody with hepatitis B virus DNA above the lower limit of quantification or 1000 copies/mL (500 IU/mL), whichever is lower;
• Positive hepatitis C virus antibody with hepatitis C virus RNA above the lower limit of quantification or 1000 copies/mL, whichever is lower.
• (Participants with detectable hepatitis B virus DNA or hepatitis C virus RNA within 6 months before screening who subsequently became undetectable after antiviral treatment are also excluded.) 14. History of human immunodeficiency virus infection or positive HIV test at screening.
• Inability or unwillingness to receive investigator-required prophylaxis against Pneumocystis jirovecii, herpes simplex virus, or herpes zoster; or a positive confirmatory syphilis test.

Where it is running

• Tongji Hospital, Tongji Medical College of Hust — Wuhan, Hubei, China

Full record on ClinicalTrials.gov

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