NCT06384482

SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma

To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.

Detailed description

The study will enroll at most 35 participants diagnosed with Recurrent/refractory small cell lung cancer or Lung large cell neuroendocrine carcinoma. There will be about 5 preset dose groups in this clinical trial, Participants will be enrolled from low dose group to high dose group. Dose escalation will be decided by the SRC (Safety Review Committee). There will be expanded cases in the aim dose group. The protocol will be performed into Screening period (-30+ days), Mononuclear cells acquisition, Lymphodepletion (-5\~-3 days), SNC115 Injection infusion and DLT observation period (day 0\~28days), and follow-up period (1-5 years). According to the administration strategy, we will start from single administration.

Conditions

• Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma

Interventions

Type	Name	Description
DRUG	SNC115 injection	SNC115 Injection is DLL3 CART.

Timeline

• Start date: 2024-04-30
• Primary completion: 2025-04-30
• Completion: 2025-12-30
• First posted: 2024-04-25
• Last updated: 2024-04-25

Locations

1 site across 1 country: China