This is a multicenter, open-label, phase I clinical trial aimed to evaluate the safety and efficacy of DLL3-CAR-NK cells treatment for relapsed and refractory extensive small cell lung cancer (ES-SCLC).
This study is a multicenter, single arm, open-label, non randomized, single dose, dose escalation, phase I clinical trial on relapsed and refractory ES-SCLC. The phase I clinical trial will be conducted according to the principle of "3 + 3". Three dose groups will be set up, namely group A: 1.0 × 10\^7, group B: 1.0 × 10\^8, and group C: 1.0 × 10\^9 DLL3-CAR-NK cells. 9-18 subjects will be enrolled in the groups and given a single infusion of DLL3-CAR-NK cells injection in order to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), evaluate the safety and efficacy of the cell infusion. It well be recommend dose for phase II clinical study (recommended phase II dose, RP2D).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Patients of Group A will be received 1x10\^7 DLL3-CAR-NK cells infusion treatment,of group B will be received 1x10\^8 DLL3-CAR-NK cells infusion treatment,and of group C will be received 1x10\^9 DLL3-CAR-NK cells infusion treatment.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe dose-limiting toxicity (DLT)
Time frame: 1 year
Maximum tolerated dose (MTD)
Time frame: 1 year
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