GC012F in Patients With Autoimmune Diseases
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorQiong Fu
About this trial
This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.
Eligibility criteria
Qualifiers
The subject or legal representative voluntarily signs the written informed consent form (ICF) personally, and is willing and able to comply with study procedures;
Aged 18 to 70 years (inclusive) at the time of signing the informed consent form, male or female;
Willing to adhere to study-specific contraception requirements until 2 years after infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present in females of childbearing potential and male subjects (whichever occurs later);
Neutrophil count ≥ 1.0 × 10^9/L; hemoglobin ≥ 80 g/L; platelet count ≥ 50 × 10^9/L;
Disqualifiers
History of severe hypersensitivity or allergy;
Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product;
New York Heart Association (NYHA) Class III or IV congestive heart failure;
Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;
Trial design
Treatments tested in this trial
- GC012F injection
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Qiong Fu
Lead sponsor
RenJi Hospital
Sponsor institution
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator
Source ClinicalTrials.gov