A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis

November 4, 2026 updated by: Daishi Tian

This is a single-arm, open-label, dose-escalating clinical trial designed to evaluate the safety, efficacy and cellular pharmacokinetics of GT802 in the treatment of refractory generalized myasthenia gravis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study includes 3 planned dose cohorts as follows: Dose 1: total of 8.5 mg, administered as 4 infusions at 1.0 mg, 1.5 mg, 3.0 mg, and 3.0 mg; Dose 2: total of 13.5 mg, administered as 4 infusions at 1.5 mg, 3.0 mg, 4.5 mg, and 4.5 mg; De-escalation dose: total of 4.5 mg, administered as 4 infusions at 0.5 mg, 1.0 mg, 1.5 mg, and 1.5 mg.

Each participant will receive treatment from one dose cohort. It is planned to enroll 4-12 participants in total, with the number of participants per dose cohort as follows: Dose 1: 1-6 participants; Dose 2: 3-6 participants; De-escalation dose: 0-6 participants.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Daishi Tian
        • Principal Investigator:
          • Chuan Qin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. The participant or their legally authorized representative voluntarily signs the written informed consent form and is willing and able to comply with the study procedures.

  • 2. Aged 18-65 years (inclusive) at the time of informed consent, without gender restriction.

  • 3. Expected survival > 12 weeks.

  • 4. Any prior systemic therapy for the indication must have a washout period of at least 4 weeks or 5 half-lives, whichever is shorter, before the participant is scheduled to receive study treatment.

  • 5. Toxicities attributable to prior treatment must have stabilized and recovered to Grade ≤1.

  • 6. Refractory generalized myasthenia gravis, as defined in the protocol.

  • 7. Screening laboratory results meet the criteria specified in the protocol.

  • 8. Pregnancy requirements:

    1. At screening, serum beta human chorionic gonadotropin (β-hCG) pregnancy test is negative as confirmed by the investigator.
    2. Agrees to refrain from breastfeeding during study participation until at least 1 year after infusion of GT802 Injection or until GT802 cells are no longer detectable by 2 consecutive flow cytometry assays, whichever occurs later.
    3. Male participants with female partners and female participants of childbearing potential agree to use highly effective contraception (e.g., oral contraceptives, intrauterine device or condoms) starting at screening and continuing until at least 1 year after infusion of GT802 Injection or until GT802 cells are no longer detectable by 2 consecutive flow cytometry assays, whichever occurs later. Male participants must agree to use condoms during sexual contact with pregnant females or females of childbearing potential for at least 1 year after GT802 Injection infusion, even after successful vasectomy.

Exclusion Criteria:

  • 1. Contraindication or hypersensitivity to any component of the investigational product.
  • 2. Presence of conditions specified in the protocol within 6 months prior to signing the informed consent form.[沈9.1]
  • 3. History of active malignancy or any malignancy within 5 years prior to screening.
  • 4. Presence of any active or untreated thymoma, or history of thymic carcinoma or other early pseudotumors of thymic malignancy.
  • 5. Autoimmune diseases other than the study disease that require systemic glucocorticoids or immunosuppressants.
  • 6. Requirement for long-term administration of medications affecting coagulation function.
  • 7. Participants with clinically obvious bleeding symptoms or definite bleeding tendency within 6 months before screening.
  • 8. Presence of severe underlying medical conditions at screening.
  • 9. Positive result for any of the following tests: 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 quantitation of the assay; c) Positive hepatitis C virus (HCV) antibody, with HCV-RNA above the lower limit of quantitation of the assay; d) Positive syphilis antibody (excluding false-positive results caused by underlying diseases).
  • 10. Positive cytomegalovirus (CMV)-DNA and Epstein Barr virus (EBV)-DNA in peripheral blood.
  • 11. Active tuberculosis prior to screening.
  • 12. Received any other investigational medicinal product within 4 weeks before signing the informed consent form (ICF).
  • 13. Received intravenous immunoglobulin, plasma exchange or immunoadsorption therapy within 4 weeks prior to study treatment.
  • 14. Received B-cell targeted therapy within 1 month prior to study treatment.
  • 15. Received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to study treatment.
  • 16. Received neonatal Fc receptor (FcRn) antagonist therapy within 2 weeks prior to study treatment.
  • 17. Received complement inhibition therapy within 2 weeks prior to study treatment.
  • 18. Received systemic glucocorticoids at a dose >10 mg/day prednisone equivalent within 7 days prior to study treatment.
  • 19. Received live attenuated vaccines or mRNA vaccines within 8 weeks before enrollment, or inactivated vaccines within 4 weeks before enrollment.
  • 20. Underwent major surgery within 8 weeks before screening, or planned to undergo surgery during the study period.
  • 21. History of organ transplantation, splenectomy, allogeneic or autologous stem cell transplantation.
  • 22. Presence of non-removable, clinically significant long-term indwelling catheters or drainage devices.
  • 23. Uncontrolled large-volume serous cavity effusion despite treatment.
  • 24. Prior receipt of CAR-T products targeting any antigen or other gene-edited cell biotherapies.
  • 25. The investigator judges that any condition exists that would prevent the participant from completing the entire trial, confound the trial results, or make trial participation not in the participant's best interest.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GT802 Injection treatment group

Participants with MG administered GT802 Injection
Biological: GT802 Injection

Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From infusion to at least 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Myasthenia Gravis (QMG) score
Time Frame: From infusion to 12 months

To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per QMG score.
From infusion to 12 months
Myasthenia Gravis Activities of Daily Living (MG-ADL) score
Time Frame: From infusion to 12 months

To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per MG-ADL score.
From infusion to 12 months
Time to maximum amplification (Tmax)
Time Frame: From infusion to 12 months

Time to maximum amplification (Tmax) of cells following GT802 infusion
From infusion to 12 months
Maximum amplification (Cmax)
Time Frame: From infusion to 12 months

The maximum observed concentration of the circulating GT802 CAR-T cells
From infusion to 12 months
Area under the curve (AUC)
Time Frame: From infusion to 12 months

Area under the curve (AUC) of cellular expansion following GT802 infusion
From infusion to 12 months
Duration of Detectable Concentration (Tlast)
Time Frame: From infusion to 12 months

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.
From infusion to 12 months
Chimeric Antigen Receptor T cell (CAR-T)-associated serum cytokines
Time Frame: From infusion to 2 months

Monitor serum cytokine levels after infusion
From infusion to 2 months
Anti-drug antibodies (ADA) Response to GT802 Measured by Immunoassay.
Time Frame: From infusion to 12 months

Changes in anti-drug antibodies (ADA) before and after treatment. Serum anti-drug antibody (ADA) response to GT802, including anti-CAR and anti-PEG antibodies, measured by immunoassay. Samples collected at pre-screening (PEG only), Day 14, Day 28, Month 3, Month 6, and Month 12 post-first infusion. Positive results trigger titer confirmation and continued monitoring until negative or below lower limit of detection.
From infusion to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daishi Tian

Collaborators

Vivacta Biotechnology (Shanghai) Co., Ltd.

Investigators

  • Principal Investigator: Chuan Qin, Tongji Hospital
  • Principal Investigator: Daishi Tian, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 30, 2031

Study Completion (Estimated)

December 30, 2031

Study Registration Dates

First Submitted

October 27, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIT-CD-CHN-802-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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