Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05507593
Brief Summary:
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).
Detailed Description:
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:
NCT05507593
Study Brief:
Protocol Section:
NCT05507593