A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relap… (NCT07748637) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relapsing/Refractory Multiple Sclerosis
China12 participantsStarted 2026-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 5\. Confirmed diagnosis of relapsed/refractory multiple sclerosis with limited effective therapeutic options at present based on specified diagnostic criteria.
* 6\. 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).
* 7\. 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 (whi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants experiencing dose limiting toxicity
Timeframe: 28 days
2
Adverse Events (AEs) occurring after infusion and their proportions