GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
ConditionAuto Immune Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrit Biotechnology
About this trial
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
Eligibility criteria
Qualifiers
1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
2. Aged 18 to 65 years (inclusive), regardless of gender.
3. Participants with systemic lupus erythematosus (SLE)
Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);
Disqualifiers
1. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;
2. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;
3. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;
4. Medical history of organ transplantation;
Trial design
Treatments tested in this trial
- GT719 Injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Grit Biotechnology
Lead sponsor
Affiliated Hospital of Nantong University
Collaborator
Source ClinicalTrials.gov