This is a single-arm, open-label, dose-escalation study to explore the safety, efficacy, and cytodynamic characteristics of the drug, and to initially observe the efficacy of the drug in subjects with relapsed/refractory B7-H3-positive acute myeloid cell line leukemia.
Eligible subjects will receive 1.0×10\^8 CAR gdT, 2.0×10\^8 CAR gdT, 4.0×10\^8 CAR gdT, or additional doses may be added at the discretion of investigator and sponsor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1E8, 2E8 and 4E8 CAR-gdT groups in order of sequence. And the subjects will be administered once.
PersonGen Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China
RECRUITINGAssessment of the safety after UTAA06 injection treatment (Safety)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: About 2 years
To evaluate anti-tumor activity (overall survival)
Defined as the time from start of UTAA06 UTAA06 infusion therapy to death (due to any cause)
Time frame: About 2 years
To evaluate anti-tumor activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR, CR or CRi to the first assessment of disease recurrence or progression or death (due to any cause).
Time frame: About 2 years
To evaluate anti-tumor activity (progression free survival)
Defined as the time from the start of UTAA06 infusion therapy to the first disease progression or recurrence or death from any cause.
Time frame: About 2 years
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