A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relapsing/Refractory Multiple Sclerosis

NCT07748637 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-802-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, dose-escalation clinical trial intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT802 for the treatment of relapsing/refractory multiple sclerosis.

Conditions

Multiple Sclerosis (MS)

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing dose limiting toxicity

  The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion

  28 days

• Adverse Events (AEs) occurring after infusion and their proportions

  Adverse Events (AEs) occurring after infusion and their proportions

  From infusion to at least 1 year

Secondary Outcomes (11)

• Expanded Disability Status Scale (EDSS) grade

  From infusion to 12 months

• Annualized relapse rate

  From infusion to 12 months

• Time to first relapse

  From infusion to at least 1 year

• Numbers of gadolinium (Gd)-enhancing T1 lesions

  From infusion to 12 months

• Numbers of new or definitely enlarged T2 lesions

  From infusion to 12 months

Other Outcomes (3)

• Changes in Oligoclonal Band level in peripheral blood and cerebrospinal fluid (CSF)

  From infusion to 12 months

• Concentration levels of neurofilament light chain protein in peripheral blood and cerebrospinal fluid (CSF)

  From infusion to 12 months

• Kappa free light chain index levels

  From infusion to 12 months

Study Arms (1)

GT802 Injection treatment group

EXPERIMENTAL

GT802 Injection

Biological: GT802 Injection

Interventions

GT802 Injection BIOLOGICAL

GT802 Injection

GT802 Injection treatment group

Eligibility Criteria

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

You may qualify if:

• \. The participant or their legally authorized representative voluntarily signs a written informed consent form and is willing and able to comply with all study procedures specified in this protocol.
• \. Aged between 18 and 65 years old inclusive at the time of informed consent signature, with no restriction on gender.
• \. For any prior systemic therapy administered for the indication, a washout period of at least 4 weeks or 5 half-lives (whichever is shorter) must have elapsed prior to the participant's scheduled administration of study treatment.
• \. Toxicities resulting from prior therapies must have stabilized and resolved to Grade ≤1, excluding clinically insignificant toxicities such as alopecia.
• \. Confirmed diagnosis of relapsed/refractory multiple sclerosis with limited effective therapeutic options at present based on specified diagnostic criteria.
• \. Screening laboratory test results shall meet the corresponding criteria (no corrective treatment with any blood products or cellular growth factors administered within 7 days prior to laboratory testing).
• \. Pregnancy-related requirements:
• a. Serum beta human chorionic gonadotropin (β-hCG) pregnancy test result is negative as confirmed by the investigator at screening.
• b. Agree to refrain from breastfeeding throughout study participation for at least 1 year after infusion of GT802 Injection, or until two consecutive flow cytometry assays confirm the absence of GT802 cells (whichever occurs later).
• c. Male participants with sexual partners and female participants of childbearing potential must agree to use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, condoms) starting at screening and continuing for at least 1 year after infusion of GT802 Injection, or until two consecutive flow cytometry assays confirm the absence of GT802 cells (whichever occurs later). Male participants must agree to use condoms during sexual intercourse with pregnant females or females of childbearing potential for a minimum of 1 year after GT802 Injection infusion, even following successful vasectomy.

You may not qualify if:

• \. Contraindication or hypersensitivity reaction to any component of the investigational product.
• \. Presence of any of the following conditions within 6 months prior to signing the informed consent form (ICF): uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (lacunar infarction excluded), coronary/peripheral artery bypass graft surgery, clinically significant arrhythmias including but not limited to ventricular arrhythmias, markedly prolonged QT interval (QTc ≥ 500 ms corrected by Bazett's formula, to be judged by the investigator), poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg), uncontrolled diabetes mellitus, diffuse pulmonary lesions, pulmonary insufficiency, or other clinically significant cardiac disorders.
• \. History of active malignant tumor or any malignancy within 5 years prior to screening. The following are exceptions: early-stage malignancies treated with curative intent (carcinoma in situ or Stage I tumors, non-ulcerated primary melanoma with depth \<1 mm and no lymph node involvement), basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or breast carcinoma in situ treated with potentially curative therapy.
• \. Any other known autoimmune disease besides the study indication.
• \. Requiring long-term administration of medications affecting blood coagulation.
• \. Subjects with clinically evident bleeding symptoms or definite bleeding diathesis within 6 months before screening, such as gastrointestinal hemorrhage, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic diatheses (e.g., hemophilia, coagulation disorders, hypersplenism, etc.); arterial or venous thromboembolic events occurring within 6 months prior to screening, including cerebrovascular diseases (cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and/or pulmonary embolism.
• \. Presence of severe underlying medical conditions at screening, such as:
• a) Evidence of uncontrolled viral, bacterial, fungal or other infections requiring systemic intravenous therapy;
• b) Distinct clinical evidence of dementia or altered mental status;
• c) History of any other central nervous system disease or neurodegenerative disease, such as epilepsy, convulsive seizures, paralysis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, psychosis.
• \. Positive test result for any of the following items:
• a) Positive human immunodeficiency virus (HIV) antibody;
• b) Positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb), with HBV-DNA above the lower limit of quantification of the assay;
• c) Positive hepatitis C virus (HCV) antibody, with HCV RNA above the lower limit of quantification of the assay;
• d) Positive syphilis antibody (excluding false-positive results caused by underlying diseases).

Sponsors & Collaborators

• Daishi Tian: lead
• Vivacta Biotechnology (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

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

Central Study Contacts

Ke Shang

CONTACT

+86 18827383157; kay_sang@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Neurology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): July 30, 2031
• Study Completion (Estimated): July 30, 2031
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)