B7-H3 (also known as CD276) is widely expressed on the surface of a variety of malignancies solid tumors, while it rarely or even doesn't express on normal tissues. Therefore, B7-H3 is an ideal target for chimeric antigen receptor (CAR) T cells therapy. TAA06 injection is a CAR T injection targeting B7-H3. This is a phase I clinical study with the primary objective of evaluating the safety and tolerability of TAA06 injection in subjects with TAA06-positive advanced solid tumors. The secondary objectives are as follows: to evaluate the distribution, proliferation and persistence of B7-H3-targeted CAR T cells after injection of TAA06 in subjects; to preliminarily evaluate the efficacy of TAA06 injection in subjects with TAA06-positive advanced solid tumor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be treated with 1×106\~1×108 CAR-T/kg. And the subjects will be administered once.
PersonGen BioTherapeutics(Suzhou) Co., Ltd.
Suzhou, Jiangsu, China
RECRUITINGAssessment of the safety after B7-H3 chimeric antigen receptor T cells infusion (Safety)
Incidence and treatment-relativity of adverse events assessed by NCI CTCAE v5.0.
Time frame: 3 months
To evaluate anti-tumor activity (overall response rate)
Rate of participants achieving a complete response (CR) or partial response (PR).
Time frame: 6 months
To evaluate anti-tumor activity (disease control rate)
Rate of participants achieving a complete response (CR) or partial response (PR) or stable disease (PD).
Time frame: 3 months
To evaluate anti-tumor activity (duration of response)
Defined as the time from the first tumor assessment of CR or PR to the first assessment of disease progression (PD) or death from any cause.
Time frame: About 2 years
To evaluate anti-tumor activity (Progression Free Survival)
Defined as the time from the date of study enrollment to the time when the investigator judges that imaging disease progression or death from any cause occurs.
Time frame: About 2 years
To evaluate anti-tumor activity (overall survival)
Defined as the time from start of the random beginning to death (due to any cause).
Time frame: About 2 years
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