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.
1. 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.
2. Aged between 18 and 65 years old inclusive at the time of informed consent signature, with no restriction on gender.
3. 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.
4. Toxicities resulting from prior therapies must have stabilized and resolved to Grade ≤1, excluding clinically insignificant toxicities such as alopecia.
1. Contraindication or hypersensitivity reaction to any component of the investigational product.
2. 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.
3. 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.
4. Any other known autoimmune disease besides the study indication.
Single group
GT802 Injection
Biological/VaccineGT802 Injection
Proportion of participants experiencing dose limiting toxicity
The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion
Adverse Events (AEs) occurring after infusion and their proportions
Adverse Events (AEs) occurring after infusion and their proportions
Expanded Disability Status Scale (EDSS) grade
Expanded Disability Status Scale (EDSS) grade,ranges from 0 to 10 points.
Annualized relapse rate
Annualized relapse rate in trial participants with relapsing-remitting multiple sclerosis (RRMS)
Time to first relapse
Time from the date of treatment initiation to the first confirmed disease relapse.
Numbers of gadolinium (Gd)-enhancing T1 lesions
Change in the number of gadolinium-enhancing T1 lesions on MRI scans
Changes in Oligoclonal Band level in peripheral blood and cerebrospinal fluid (CSF)
Changes in oligoclonal band levels in peripheral blood and cerebrospinal fluid (CSF) from baseline.
Concentration levels of neurofilament light chain protein in peripheral blood and cerebrospinal fluid (CSF)
Changes from baseline in concentrations of neurofilament light chain (NfL) in peripheral blood and cerebrospinal fluid (CSF)
Kappa free light chain index levels
In kappa free light chain index levels in peripheral blood and cerebrospinal fluid (CSF)
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Daishi Tian
Lead sponsor
Tongji Hospital
Sponsor institution
Vivacta Biotechnology (Shanghai) Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
