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Moderate to Severe Refractory Autoimmune DiseasesEarly Phase 1NCT07614191

A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases

A Early Phase 1 study testing GT801 Injection in people with Moderate to Severe Refractory Autoimmune Diseases, run by Vivacta Biotechnology (Shanghai) Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy and cellular pharmacokinetics of GT801 injection in patients with moderate to severe refractory autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
GT801 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
25 May 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 legal representative voluntarily signs a written informed consent form and is willing and able to comply with the study procedures.
  • 2. Aged 18 to 65 years old (inclusive) at the time of signing the informed consent, regardless of gender.
  • 3.subjects should be diagnosed with recurrent or refractory autoimmune diseases, including but not limited to systemic lupus erythematosus (SLE), lupus nephritis (LN), membranous nephropathy (MN), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV), Sjogren's Syndrome.
  • 4.Organ function meets the corresponding criteria.
  • 5.Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening and agree to avoid breastfeeding during study participation until at least 1 year after GT801 injection or until GT801 cells are no longer detectable by two consecutive flow cytometry tests, whichever is later.

Who cannot join

  • 1. History of severe hypersensitivity reactions or allergies.
  • 2. Contraindications to or hypersensitivity reactions to any component of the investigational product.
  • 3. History of the following cardiac diseases:
  • a. New York Heart Association (NYHA) Class III or IV congestive heart failure.
  • b. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening.
  • c. History of clinically significant ventricular arrhythmia or unexplained syncope not caused by vasovagal response or dehydration; or corrected QT interval (QTc) > 480 ms at screening; history of severe non-ischemic cardiomyopathy.
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  • 4. History of any active malignancy or malignant tumor within 5 years prior to screening, except for the following conditions: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumors, non-ulcerative primary melanoma with depth < 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast that has undergone potentially curative treatment.
  • 5. Any other known autoimmune diseases besides the study disease.
  • 6. Long-term use of anticoagulant drugs that affect coagulation function.
  • 7. Clinically significant bleeding symptoms or confirmed bleeding tendency within 6 months prior to screening (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.); hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, hypersplenism, etc.); arterial or venous thrombotic events within 6 months prior to screening (e.g., cerebrovascular diseases including cerebral hemorrhage and cerebral infarction, deep vein thrombosis, and/or pulmonary embolism).
  • 8. Subjects with active virus infection including Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), Hepatitis C virus (HCV), cytomegalovirus (CMV), syphilis and tuberculosis etc.
  • 9. Receipt of other investigational drugs within 4 weeks prior to signing the informed consent form (ICF); or the interval between the ICF signing date and the last dose of the previous clinical trial participation is still within 5 half-lives of the drug, whichever is longer.
  • 10. Receipt of plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to investigational product administration.
  • 11. Prior treatment with B-cell targeted therapies within 3 months prior to study drug administration (the investigator may make appropriate adjustments according to the participant's condition), including but not limited to rituximab, belimumab, telitacicept, etc.
  • 12. Receipt of biologic therapy such as anti-TNF-α antibodies within 12 weeks prior to investigational product administration.
  • 13. Use of tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to investigational product administration.
  • 14. Receipt of neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod, etc.) within 3 weeks prior to investigational product administration.
  • 15. Receipt of complement inhibition therapy (e.g., eculizumab, etc.) within 3 weeks prior to investigational product administration.
  • 16. Vaccination with live attenuated vaccines or mRNA vaccines within 8 weeks prior to enrollment; or inactivated vaccines within 4 weeks prior to enrollment.
  • 17. Major surgery within 8 weeks prior to screening, or planned surgery during the study period.
  • 18. History of organ transplantation.
  • 19. Prior receipt of chimeric antigen receptor T-cell (CAR-T) therapy targeting any antigen.
  • 20. Presence of any conditions that, in the investigator's judgment, would prevent the participant from completing the entire trial, confound 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.

Hong Cai contact

+86 18621576622

18621576622@163.com

China1 site, 1 recruiting

  • Renji Hospital

    Shanghai, Shanghai Municipality, 200127

    Hong Cai, +86 18621576622, 18621576622@163.com

    Hong Cai

    Recruiting

Other trials in China

About this study

This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy and cellular pharmacokinetics of GT801 injection in patients with moderate to severe refractory autoimmune diseases.

Being tested
GT801 Injection

What participants receive

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

  • GT801 InjectionBiological

    GT801 Injection

Study groups in NCT07614191
Study groupRoleWhat they receive
GT801 Injection treatment groupExperimentalGT801 Injection
Receives: Biological: GT801 Injection

What is being measured

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

  1. 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

  2. Adverse Events (AEs) occurring after infusion and their proportions

    Adverse Events (AEs) occurring after infusion and their proportions

    Measured: 3 months

Secondary outcomes (13)

  1. Efficacy outcomes for Systemic Lupus Erythematosus (SLE)

    SLE Response index 4(SRI-4) response: Min/Max Value: Not specified; a decrease in score indicates improvment, higher scores indicate worse outcome

    Measured: 1, 2, 3 and 6 Months post GT801 infusion

  2. Efficacy outcomes for lupus nephritis (LN)

    Renal response rate

    Measured: 1, 2, 3 and 6 Months post GT801 infusion

  3. Efficacy outcomes for membranous nephropathy (MN)

    Renal response rate

    Measured: 1, 2, 3 and 6 Months post GT801 infusion

  4. Efficacy outcomes for Idiopathic Inflammatory Myopathies (IIM)

    Total lmprovement Score (TlS): Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome.

    Measured: 1, 2, 3 and 6 Months post GT801 infusion

  5. Efficacy outcomes for Systemic Sclerosis (SSc)

    Combined Response Index in Systemic Sclerosis (CRISS): the score ranges from 0 to 1 point; a score ≥ 0.6 indicates treatment improvement, while a score < 0.6 indicates no disease improvement.

    Measured: 1, 2, 3 and 6 Months post GT801 infusion

  6. Efficacy Outcomes for ANCA-Associated Vasculitis (AAV)

    The proportion of subjects achieving complete remission and partial remission

    Measured: 6 and 12 Months post GT801 infusion

  7. Efficacy Outcomes for Participants with Sjogren's Syndrome

    EULAR Sjögren's Syndrome Disease Activity Index （ESSDAI）response rates

    Measured: 6 and 12 Months post GT801 infusion

  8. Efficacy Outcomes for Participants with Sjogren's Syndrome

    EULAR Sjögren's Syndrome Patient-Reported Index （ESSPRI）response rates

    Measured: 6 and 12 Months post GT801 infusion

  9. Cellular Kinetics of All Participants: Time to Peak Expansion of GT801 Cells After Infusion (Tmax)

    Time to Peak Expansion (Tmax) refers to the time point at which the infused target cells proliferate to the peak quantity in the participants' bodies.

    Measured: From infusion to 12 months

  10. Cellular Kinetics of All Participants: Expansion Peak of GT801 Cells After Infusion (Cmax)

    Expansion Peak (Cmax) refers to the maximum quantity of infused GT801 cells achieved during their proliferation in the participants' bodies.

    Measured: From infusion to 12 months

  11. Cellular Kinetics of All Participants: Area Under the Curve (AUC) of GT801 Cells After Infusion

    Area Under the Curve (AUC) refers to the area enclosed by the curve of GT801 cell quantity change over time after infusion and the time axis.

    Measured: From infusion to 12 months

  12. Cellular Kinetics of All Participants: Duration of Detectable Concentration of GT801 Cells After Infusion (Tlast)

    Duration of Detectable Concentration (Tlast) refers to the time period from the infusion of GT801 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

  13. Pharmacodynamic characteristics in participants for all participants

    Monitor serum cytokine levels after infusion

    Measured: From infusion to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2026
  2. Study start25 May 2026
  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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07614191
Sponsor's protocol ID
GRIT-CD-CHN-801-005
Status last verified
May 2026
First submitted
13 May 2026
Last updated
2 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing GT801 Injection in people with Moderate to Severe Refractory Autoimmune Diseases, run by Vivacta Biotechnology (Shanghai) Co., Ltd. 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 5 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 2 Jun 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 Hong Cai (+86 18621576622, 18621576622@163.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?

On the ClinicalTrials.gov record for NCT07614191.

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 2 Jun 2026.

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