Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune Diseases
Led by Grit Biotechnology · Updated on 2026-01-12
22
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
G
Grit Biotechnology
Lead Sponsor
S
Shanghai Changzheng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy, and cellular metabolism kinetics of GT801 in the treatment of moderate-to-severe refractory autoimmune diseases.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The participant or legal representative signs informed consent and agrees to study procedures.
- Age between 18 and 65 years inclusive.
- For Systemic Lupus Erythematosus (SLE): meets 2019 EULAR/ACR criteria; SLEDAI-2000 score ≥ 6 with specific organ involvement or score ≥ 8; refractory or relapsing disease after conventional treatment.
- For Idiopathic Inflammatory Myopathy (IIM): meets 2017 EULAR/ACR criteria; positive myositis antibodies; moderate to severe disease per MMT-8 score or other assessments; refractory/relapsing or progressive disease.
- For Systemic Sclerosis (SSc): meets 2013 ACR criteria; positive SSc antibodies; refractory/relapsing or progressive disease.
- For ANCA-Associated Vasculitis (AAV): meets 2022 ACR/EULAR criteria; positive ANCA antibodies; active vasculitis with BVAS ≥ 15; refractory/relapsing disease.
- For Sjogren's Syndrome: meets 2002 AECG or 2016 ACR/EULAR criteria; ESSDAI score ≥ 6; positive anti-SSA/Ro antibodies; refractory/relapsing disease.
- Screening lab tests within set limits for neutrophils, hemoglobin, platelets, liver enzymes, bilirubin, creatinine clearance, coagulation, heart function, and oxygen saturation.
- Women of childbearing potential must have negative pregnancy test and agree to avoid breastfeeding and use effective contraception during and after study.
- Male participants with partners and females of childbearing potential must agree to use contraception as specified.
You will not qualify if you...
- SLE patients with drug-induced lupus, lupus crisis, or requiring prohibited drugs.
- IIM patients with inclusion body myositis, drug-induced myositis, malignancy-associated myositis, or non-inflammatory myopathies.
- IIM patients with uncontrolled lung disease (FVC < 55% or oxygen therapy), severe swallowing or cardiac issues.
- SSc patients with severe pulmonary arterial hypertension, severe gastrointestinal involvement, or uncontrolled lung disease with oxygen saturation < 92%.
- AAV patients with rapidly progressive glomerulonephritis, severe vasculitis manifestations, or secondary vasculitis.
- Sjogren's Syndrome patients with poorly controlled severe systemic disease, secondary Sjogren's, medications causing dry mouth/eyes, or interfering diseases.
- History of severe allergies or hypersensitivity reactions.
- Presence of anti-PEG antibodies before infusion.
- Contraindications or hypersensitivity to study product components.
- Significant cardiac diseases including severe heart failure, recent heart attack, serious arrhythmias, or cardiomyopathy.
- Active malignancy within 5 years except specified early-stage cancers.
- Other autoimmune diseases not under study.
- Long-term use of anticoagulants or bleeding disorders.
- Severe infections, dementia, CNS diseases, or neurodegenerative disorders.
- Positive tests for HIV, hepatitis B or C, syphilis, CMV, or EBV.
- Active or untreated latent tuberculosis.
- Recent use of other investigational drugs, plasma exchange, B-cell therapies, biologics, or immunosuppressants within specified timeframes.
- Recent vaccination with live, mRNA, or inactivated vaccines within specified periods.
- Recent major surgery or planned surgery during study.
- History of organ transplantation or prior CAR-T therapy.
- Any condition judged to prevent trial completion or confound results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
Research Team
H
Huji Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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