GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
ConditionAutoimmune Diseases
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, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study.
Eligibility criteria
Qualifiers
Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
Aged 18 to 65 years (inclusive), regardless of gender.
Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×10^9/L; Hemoglobin ≥80g/L; Platelets ≥30×10^9/L;
Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
Disqualifiers
Drug induced SLE;
Patients with lupus crisis or concomitant diseases who require the use of contraindicated drugs according to the protocol are deemed unsuitable for inclusion by the investigator.
IIM participants
Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor associated PM or DM, non-inflammatory myopathy (such as muscular dystrophy);
Trial design
Treatments tested in this trial
- GT719 Injection
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov