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

NCT07614191 | Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-801-005
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moderate to Severe Refractory Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing dose limiting toxicity

  The proportion of participants with dose-limiting toxicity (DLT) occurring within 28 days after infusion

  28 days

• Adverse Events (AEs) occurring after infusion and their proportions

  Adverse Events (AEs) occurring after infusion and their proportions

  3 months

Secondary Outcomes (13)

• Efficacy outcomes for Systemic Lupus Erythematosus (SLE)

  1, 2, 3 and 6 Months post GT801 infusion

• Efficacy outcomes for lupus nephritis (LN)

  1, 2, 3 and 6 Months post GT801 infusion

• Efficacy outcomes for membranous nephropathy (MN)

  1, 2, 3 and 6 Months post GT801 infusion

• Efficacy outcomes for Idiopathic Inflammatory Myopathies (IIM)

  1, 2, 3 and 6 Months post GT801 infusion

• Efficacy outcomes for Systemic Sclerosis (SSc)

  1, 2, 3 and 6 Months post GT801 infusion

Study Arms (1)

GT801 Injection treatment group

EXPERIMENTAL

GT801 Injection

Biological: GT801 Injection

Interventions

GT801 Injection BIOLOGICAL

GT801 Injection

GT801 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant or their legal representative voluntarily signs a written informed consent form and is willing and able to comply with the study procedures.
• \. Aged 18 to 65 years old (inclusive) at the time of signing the informed consent, regardless of gender.
• 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.
• Organ function meets the corresponding criteria.
• 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.

You may not qualify if:

• \. History of severe hypersensitivity reactions or allergies.
• \. Contraindications to or hypersensitivity reactions to any component of the investigational product.
• \. 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.
• \. 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.
• \. Any other known autoimmune diseases besides the study disease.
• \. Long-term use of anticoagulant drugs that affect coagulation function.
• \. 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).
• \. Subjects with active virus infection including Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), Hepatitis C virus (HCV), cytomegalovirus (CMV), syphilis and tuberculosis etc.
• \. 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.
• \. Receipt of plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to investigational product administration.
• \. 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.
• \. Receipt of biologic therapy such as anti-TNF-α antibodies within 12 weeks prior to investigational product administration.

Sponsors & Collaborators

• Vivacta Biotechnology (Shanghai) Co., Ltd.: lead
• RenJi Hospital: collaborator

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Central Study Contacts

Hong Cai

CONTACT

+86 18621576622; 18621576622@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 29, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)