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Tests treatment safety and results for Moderate to Severe Refractory Autoimmune Diseases
Official title A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07614191
What this study is testing
What is GT801 Injection?
GT801 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for moderate to severe refractory autoimmune diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 1.The participant or their legal representative voluntarily signs a written informed consent form and is willing and able to comply with the study...
- 2\. Aged 18 to 65 years old (inclusive) at the time of signing the informed consent, regardless of gender.
- 3.people should be diagnosed with recurrent or refractory autoimmune diseases, including but not limited to systemic lupus erythematosus (SLE), lupus...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- 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.people 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...
- 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...
- 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...
- 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...
- 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...
- 8\. people 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.