An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
SUV2208A, DL1, 2 times, Day 0 and Day 28, IV
SUV2208A, DL2, 2 times, Day 0 and Day 28, IV
SUV2208A, DL3, 2 times, Day 0 and Day 28, IV
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
RECRUITINGDLT
DLT incidence within 24 days after infusion of SUV2208A.
Time frame: within 24 days from Day 0
AE/SAE
The incidence, severity, and corelaton of adverse events (AE) and serious adverse events (SAE).
Time frame: within 2 years from Day 0
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