Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). Secondary purpose: To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.
This clinical trial was designed as a single-arm, open-label, single-center, investigator-initiated early-stage clinical study to evaluate the safety of UTAA09 injection in patients with relapsed/refractory AID. After signing the informed consent letter, qualified subjects were screened for infusion of UTAA09 injection, and their blood was collected before and after infusion for pharmacokinetics, pharmacodynamics, immunogenicity, safety and other evaluation. In addition to the baseline period, the therapeutic efficacy was evaluated at the frequency of 14d, 28d, 2m, 4m, 6m, 8m, 10m, 12m, 15m, 18m, 21m, 24m after cell transfusion until disease progression (PD), new anti-disease therapy, death, intolerable toxicity, investigator decision, or subject's voluntary withdrawal. Whichever comes first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Intravenous administration, 1 bag each time (depending on individual differences), dose: 1×108-1×109 CD19-CAR-gdT (UTAA09 injection), the investigator can decide whether to reduce or increase the dose and whether multiple infusions are required according to the condition of the subject.
PersonGen.Anke Cellular Therapeutice Co., Ltd
Hefei, China
RECRUITINGAE
Type, frequency, and severity of adverse events (AEs) and laboratory abnormalities according to the Common Adverse Event Evaluation Standard NCI CTCAE version 5.0
Time frame: 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Cmax
The maximum amplified concentration (Cmax) of UTAA09 injection in peripheral blood after administration, the time to reach the maximum concentration (Tmax), and the area under the curve AUC0-28d at 28 days and the area under the curve AUC0-90d at 90 days
Time frame: 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
CD19-positive cells
The content of CD19-positive cells in peripheral blood after UTAA09 injection administration: the proportion and absolute value of CD19-positive cells in peripheral blood at each time point; Concentration levels of CAR-T-associated serum cytokines.
Time frame: 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
Disease remission/response/improvement rates
Disease remission/response/improvement rates at 28 days, 2 months, and 3 months after administration.
Time frame: 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
anti-CAR antibody
The positive rate of human anti-CAR antibody at each time point.
Time frame: 3 months after cell reinfusion or disease progression/recurrence or start of new anti-disease therapy (whichever occurs first)
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