Clinical Study of CD7 CAR-T Cells for Relapsed/refractory Autoimmune Diseases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
About this trial
The primary objective was to evaluate the safety of CD7 CAR-T cells for the treatment of subjects with relapsed/refractory AID. CD7 CAR-T cells were infused in a single infusion in subjects who were screened after signing an informed consent form and undergoing single nucleus cell collection and pretreatment, and blood was collected before and after the infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety evaluations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
T cell injection targeting CD7 chimeric antigen receptor
Biological/VaccineSubjects who sign the informed consent form and meet the inclusion/exclusion criteria will be entered into the 0.25×108, 1×108 and 2×108 CAR-T groups, in order of priority, and will be administered 1 dose of
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: T cell injection targeting CD7 chimeric antigen receptorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
About 1 yearSecondary outcomes
1
（Cmax）
Maximum concentration of CD7 CAR-T cells expanded in peripheral blood after drug administration
Time frame
About 1 year2
（Tmax）
Time to maximum concentration
Time frame
About 1 year3
AUC0-28d
Area under the curve at 28 days
Time frame
About 28 days4
AUC0-90d
Area under the curve at 90 days
Time frame
About 90 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: