A Study of IMS001 in Patients With Multiple Sclerosis

Inclusion Criteria:

1. Voluntarily provides written informed consent.

2. Aged 18 to 65 years, inclusive, of either sex.

3. Has relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), diagnosed according to the 2017 McDonald criteria.

4. Has an Expanded Disability Status Scale (EDSS) score of 3.0 to 7.5, inclusive.

5. Has experienced at least one of the following despite disease-modifying therapy (DMT):

   • One relapse within the year before screening, or at least two relapses within the two years before screening.
   • Confirmed disability progression, as assessed by the investigator.
   • Gadolinium-enhancing T1 lesions and/or new or enlarging T2 lesions on magnetic resonance imaging (MRI).

6. Has had no clinical relapse within one month before screening.

7. Has had multiple sclerosis for more than one year.

8. Women of childbearing potential must agree to use effective contraception during the study and for six months after the last dose of study treatment, and must have negative pregnancy tests at screening and baseline.

9. Male participants with partners of childbearing potential must agree to use effective contraception for three months after the last dose of study treatment and must not donate sperm during this period.

10. Is able and willing to undergo gadolinium administration and repeated MRI examinations.

Exclusion Criteria:

1. Known or suspected allergy to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any component of IMS001.
2. Use of teriflunomide within 12 months before screening, unless an 11-day elimination procedure using cholestyramine or another appropriate elimination agent has been completed.
3. Use of alemtuzumab within 12 months before screening, or cladribine, rituximab, ocrelizumab, or another anti-CD20 monoclonal antibody within six months before screening.
4. Use of ofatumumab, natalizumab, or ozanimod, or treatment with plasma exchange, within three months before screening.
5. Use of mitoxantrone, cyclophosphamide, azathioprine, methotrexate, cyclosporine, mycophenolate mofetil, fingolimod, siponimod, ponesimod, or systemic corticosteroids within one month before screening.
6. Use of interferon beta-1a/1b, glatiramer acetate, dimethyl fumarate, diroximel fumarate, or monomethyl fumarate within two weeks before screening. Generic equivalents of glatiramer acetate and dimethyl fumarate are included.
7. Previous treatment with any allogeneic cell therapy or tissue transplantation.
8. History of a neoplastic disease, except basal cell carcinoma; nonmetastatic cutaneous squamous cell carcinoma excised with clear margins; adequately treated cervical carcinoma in situ; or low-risk differentiated papillary thyroid carcinoma or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) that has been definitively treated, without recurrence, and meets the required disease-free survival criteria.
9. Clinically significant electrocardiogram abnormalities during screening.
10. Known or documented HIV or syphilis infection, or active hepatitis B or hepatitis C infection.
11. Abnormal liver function, including total bilirubin greater than 2 times the upper limit of normal (ULN), except isolated Gilbert syndrome, or AST or ALT greater than 3 times ULN.
12. White blood cell count below 3 × 10^9/L; lymphocyte count below 0.8 × 10^9/L; hemoglobin below 90 g/L; or platelet count below 80 × 10^9/L.
13. Estimated glomerular filtration rate below 30 mL/min/1.73 m² during screening, calculated using the 2021 CKD-EPI equation; acute kidney injury; need for renal replacement therapy; or another clinically significant active or unstable kidney disease, as judged by the investigator.
14. History of another autoimmune disease, myelodysplasia, or a hematological disease.
15. Pregnancy, breastfeeding, or plans to become pregnant during the study.
16. Inability to receive study treatment during the trial, likely noncompliance with the protocol, or any other circumstance considered unsuitable by the investigator.
17. Participation in another clinical trial of a drug or device within three months before enrollment.