NCT05507593

Study of DLL3-CAR-NK Cells in the Treatment of Extensive Stage Small Cell Lung Cancer

A Multicenter Phase I Trial on the Safety and Preliminary Efficacy of DLL3-CAR-NK Cells in the Treatment of Relapsed / Refractory Extensive Stage Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• SCLC, Extensive Stage

Interventions

Type	Name	Description
BIOLOGICAL	DLL3-CAR-NK cells	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-01
• Completion: 2023-07-01
• First posted: 2022-08-19
• Last updated: 2022-08-19

Locations

1 site across 1 country: China