Multiple Sclerosis (MS)Early Phase 1NCT07748637
A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relapsing/Refractory Multiple Sclerosis
A Early Phase 1 study testing GT802 Injection in people with Multiple Sclerosis (MS), run by Daishi Tian at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- GT802 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2026to 30 Jul 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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 (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.
Who cannot join
- 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.
- 5. Requiring long-term administration of medications affecting blood coagulation.
- 6. 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.
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- 7. 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.
- 8. 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).
- 9. Positive cytomegalovirus (CMV)-DNA and Epstein-Barr virus (EBV)-DNA tests (plasma + peripheral blood mononuclear cells [PBMC]).
- 10. Active tuberculosis or latent tuberculosis infection without appropriate treatment prior to screening.
- 11. Received another investigational medicinal product within 4 weeks before ICF signature, or the interval from the last administration of the previous clinical trial drug to ICF signature is still within 5 half-lives of the drug (whichever is longer).
- 12. Received intravenous immunoglobulin (IVIG), plasma exchange or immunoadsorption therapy within 4 weeks prior to study treatment initiation.
- 13. Received B-cell-targeted therapy within 1 month prior to study treatment initiation, including but not limited to rituximab, belimumab, telitacicept, etc.
- 14. Received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to study treatment initiation.
- 15. Received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod, etc.) within 2 weeks prior to study treatment initiation.
- 16. Received complement inhibition therapy (e.g., eculizumab, etc.) within 2 weeks prior to study treatment initiation.
- 17. Received systemic glucocorticoids at a daily dose ≥10 mg prednisone equivalent within 7 days prior to study treatment initiation (inhaled glucocorticoids excluded).
- 18. Received live attenuated vaccines or mRNA vaccines within 8 weeks before enrollment, or inactivated vaccines within 4 weeks before enrollment.
- 19. Underwent major surgery within 8 weeks prior to screening, or scheduled to receive surgical procedures during the study period.
- 20. History of solid organ transplantation, splenectomy, allogeneic or autologous stem cell transplantation.
- 21. Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drainage tube, pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
- 22. Uncontrolled massive serous effusions despite treatment (e.g., pleural effusion, ascites, pericardial effusion).
- 23. Prior administration of CAR-T products targeting any antigen or other gene-edited cellular biotherapies.
- 24. History of other autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus, etc.) within the past 2 years that have caused end-organ damage or required systemic immunosuppression, except for the disease population specified in the inclusion criteria.
- 25. Any condition that, in the investigator's judgment, would interfere with the subject's full participation in the trial, confound study results, or render trial participation inconsistent with the subject's best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Daishi Tian, +86 13607178809, tiands@tjh.tjmu.edu.cn
Daishi Tian
About this study
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.
Read the detailed description
The study consists of three dose groups as follows:
Dose Level 1: Total dose of 8.5 mg, administered via 4 separate intravenous infusions at doses of 1.0 mg, 1.5 mg, 3.0 mg and 3.0 mg; Dose Level 2: Total dose of 13.5 mg, administered via 4 separate intravenous infusions at doses of 1.5 mg, 3.0 mg, 4.5 mg and 4.5 mg; De-escalation Dose: Total dose of 4.5 mg, administered via 4 separate intravenous infusions at doses of 0.5 mg, 1.0 mg, 1.5 mg and 1.5 mg.
It is planned to enroll 4-12 participants in total. The planned number of participants for each dose group is specified below:
Dose Level 1: 1-6 participants; Dose Level 2: 3-6 participants; De-escalation Dose: 1-6 participants.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- GT802 Injection
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT802 InjectionBiological
GT802 Injection
| Study group | Role | What they receive |
|---|---|---|
| GT802 Injection treatment group | Experimental | GT802 Injection Receives: Biological: GT802 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants experiencing dose limiting toxicity
The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion
Measured: 28 days
Adverse Events (AEs) occurring after infusion and their proportions
Adverse Events (AEs) occurring after infusion and their proportions
Measured: From infusion to at least 1 year
Secondary outcomes (11)
Expanded Disability Status Scale (EDSS) grade
Expanded Disability Status Scale (EDSS) grade,ranges from 0 to 10 points.
Measured: From infusion to 12 months
Annualized relapse rate
Annualized relapse rate in trial participants with relapsing-remitting multiple sclerosis (RRMS)
Measured: From infusion to 12 months
Time to first relapse
Time from the date of treatment initiation to the first confirmed disease relapse.
Measured: From infusion to at least 1 year
Numbers of gadolinium (Gd)-enhancing T1 lesions
Change in the number of gadolinium-enhancing T1 lesions on MRI scans
Measured: From infusion to 12 months
Numbers of new or definitely enlarged T2 lesions
Number of new or definitely enlarged T2 lesions identified on MRI compared with baseline.
Measured: From infusion to 12 months
Levels of Interleukins
Monitor serum cytokine levels after infusion
Measured: From infusion to 12 months
Anti-drug antibodies (ADA)
Changes in anti-drug antibodies (ADA) before and after treatment
Measured: From infusion to 12 months
Duration of Detectable Concentration (Tlast)
Duration of Detectable Concentration (Tlast) refers to the time period from the infusion of GT802 cells to the last time point at which the target cells can be detected in the peripheral blood or target tissues.
Measured: From infusion to 12 months
Time to maximum amplification (Tmax)
Time to maximum amplification (Tmax) of cells following GT802 infusion
Measured: From infusion to 12 months
Maximum amplification (Cmax)
The maximum observed concentration of the circulating GT802 CAR-T cells
Measured: From infusion to 12 months
Area under the curve (AUC)
Area under the curve (AUC) of cellular expansion following GT802 infusion
Measured: From infusion to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start28 Oct 2026 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daishi Tian
- Sponsor type
- University, hospital or other
- Collaborators
- Vivacta Biotechnology (Shanghai) Co., Ltd.
- Responsible party
- Sponsor-investigator, Daishi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748637
- Sponsor's protocol ID
- GRIT-CD-CHN-802-002
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Relapsing/Refractory Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07748637
- Acronym / sponsor ID
- GRIT-CD-CHN-802-002
- Conditions
- Multiple Sclerosis (MS)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Daishi TianUniversity, hospital or other
- Collaborators
- Vivacta Biotechnology (Shanghai) Co., Ltd.
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of three dose groups as follows:
Dose Level 1: Total dose of 8.5 mg, administered via 4 separate intravenous infusions at doses of 1.0 mg, 1.5 mg, 3.0 mg and 3.0 mg; Dose Level 2: Total dose of 13.5 mg, administered via 4 separate intravenous infusions at doses of 1.5 mg, 3.0 mg, 4.5 mg and 4.5 mg; De-escalation Dose: Total dose of 4.5 mg, administered via 4 separate intravenous infusions at doses of 0.5 mg, 1.0 mg, 1.5 mg and 1.5 mg.
It is planned to enroll 4-12 participants in total. The planned number of participants for each dose group is specified below:
Dose Level 1: 1-6 participants; Dose Level 2: 3-6 participants; De-escalation Dose: 1-6 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT802 Injection treatment group | Experimental | Biological: GT802 InjectionGT802 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
- 5. Requiring long-term administration of medications affecting blood coagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT802 InjectionGT802 Injection | Biological | GT802 Injection treatment group |
Primary outcome
Proportion of participants experiencing dose limiting toxicity
Time frame: 28 days
The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion
Adverse Events (AEs) occurring after infusion and their proportions
Time frame: From infusion to at least 1 year
Adverse Events (AEs) occurring after infusion and their proportions
11 secondary outcomes
Expanded Disability Status Scale (EDSS) grade
Time frame: From infusion to 12 months
Annualized relapse rate
Time frame: From infusion to 12 months
Time to first relapse
Time frame: From infusion to at least 1 year
Numbers of gadolinium (Gd)-enhancing T1 lesions
Time frame: From infusion to 12 months
Numbers of new or definitely enlarged T2 lesions
Time frame: From infusion to 12 months
Levels of Interleukins
Time frame: From infusion to 12 months
Anti-drug antibodies (ADA)
Time frame: From infusion to 12 months
Duration of Detectable Concentration (Tlast)
Time frame: From infusion to 12 months
Time to maximum amplification (Tmax)
Time frame: From infusion to 12 months
Maximum amplification (Cmax)
Time frame: From infusion to 12 months
Area under the curve (AUC)
Time frame: From infusion to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GT802 Injection in people with Multiple Sclerosis (MS), run by Daishi Tian at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke Shang (+86 18827383157, kay_sang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing dose limiting toxicity (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.