Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384482
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-10
Brief Title:
SNC115 Injections in Patients With RecurrentRefractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma
Sponsor:
Shanghai Simnova Biotechnology CoLtd
Organization:
Shanghai Simnova Biotechnology CoLtd
Study Overview
Official Title:
To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With RecurrentRefractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma an Open-label Single-arm Dose Escalation Exploratory Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Recurrentrefractory small cell lung cancer and Lung large cell neuroendocrine carcinoma
Detailed Description:
The study will enroll at most 35 participants diagnosed with Recurrentrefractory 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 028days and follow-up period 1-5 years According to the administration strategy we will start from single administration
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 028days and follow-up period 1-5 years According to the administration strategy we will start from single administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None