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Generalized Myasthenia Gravis (gMG)Early Phase 1NCT07917923

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

A Early Phase 1 study testing GT802 Injection in people with Generalized Myasthenia Gravis (gMG), run by Daishi Tian at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Generalized Myasthenia Gravis (gMG)
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
Dec 2026to 30 Dec 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 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.
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  • 7. Screening laboratory results meet the criteria specified in the protocol.
  • 8. Pregnancy requirements:
  • At screening, serum beta human chorionic gonadotropin (β-hCG) pregnancy test is negative as confirmed by the investigator.
  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuhang Cheng contact

+86 13125197960

chengyh_tj@163.com

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

Other trials in China

About this study

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.

Read the 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.

Being tested
GT802 Injection
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT802 InjectionBiological

    Injection

Study groups in NCT07917923
Study groupRoleWhat they receive
GT802 Injection treatment groupExperimentalParticipants with MG administered GT802 Injection
Receives: Biological: GT802 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (8)

  1. Quantitative Myasthenia Gravis (QMG) score

    To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per QMG score.

    Measured: From infusion to 12 months

  2. Myasthenia Gravis Activities of Daily Living (MG-ADL) score

    To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per MG-ADL score.

    Measured: From infusion to 12 months

  3. Time to maximum amplification (Tmax)

    Time to maximum amplification (Tmax) of cells following GT802 infusion

    Measured: From infusion to 12 months

  4. Maximum amplification (Cmax)

    The maximum observed concentration of the circulating GT802 CAR-T cells

    Measured: From infusion to 12 months

  5. Area under the curve (AUC)

    Area under the curve (AUC) of cellular expansion following GT802 infusion

    Measured: From infusion to 12 months

  6. 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

  7. Chimeric Antigen Receptor T cell (CAR-T)-associated serum cytokines

    Monitor serum cytokine levels after infusion

    Measured: From infusion to 2 months

  8. Anti-drug antibodies (ADA) Response to GT802 Measured by Immunoassay.

    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.

    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.

  1. First posted5 Nov 2026
  2. Study startDec 2026 (estimated)
  3. Primary completion30 Dec 2031 (estimated)
  4. Study completion30 Dec 2031 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07917923
Sponsor's protocol ID
GRIT-CD-CHN-802-003
Status last verified
Nov 2026
First submitted
27 Oct 2026
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GT802 Injection in people with Generalized Myasthenia Gravis (gMG), 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 11 inclusion and 25 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 5 Nov 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 Yuhang Cheng (+86 13125197960, chengyh_tj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) occurring after infusion and their proportions (time frame: From infusion to at least 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07917923.

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 5 Nov 2026.

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