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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GC012F injection
DrugSubjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: 3.0×10^5 CAR-T cells/kgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects with dose-limiting toxicity (DLT) within 28 days after infusion.
Time frame
28 days after infusion.2
Post-infusion adverse events and their proportion.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.Secondary outcomes
1
Chimeric antigen receptor T cell (CAR-T) levels in peripheral blood at each time point.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.2
Chimeric antigen receptor transgene levels in peripheral blood at each time point.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.3
Quantification of cytokines in peripheral blood at each time point.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.4
Quantification of immunoglobulins in peripheral blood at each time point.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.Other outcomes
1
Detection rate of CAR-T cell antibody after GC012F infusion.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.2
Changes in antibody concentrations resulting from previous vaccination.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.3
Detection rate of RCL after GC012F infusion.
Time frame
From the signing of informed consent through 672 days (96 weeks) after cell infusion or initiation of a new therapy, whichever occurs first.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Qiong Fu
Lead sponsor
RenJi Hospital
Sponsor institution
Gracell Biotechnologies (Shanghai) Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: