Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348797
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-18
Brief Title:
Phase I Clinical Study of α-PD-L1DLL3 CAR-T in Patients With RR SCLC
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L14-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer SCLC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
A study to evaluate the safety and feasibility of α-PD-L14-1BB DLL3 Chimeric Antigen Receptor CAR-T BHP01 in patients with RelapsedRefractory Small Cell Lung Cancer SCLC and determine the appropriate CAR-T cell dose Next In dose expansion phase patients were assign two groups withwithout bridge radiotherapy
Detailed Description:
Small cell lung cancer SCLC accounts for about 15 of lung cancers and two-thirds of cases are metastatic at the time of diagnosis The inhibitory notch ligand delta-like ligand 3 DLL3 is aberrantly expressed on the surface of up to 85 of SCLC cells and minimally expressed in normal tissues making it a compelling therapeutic target This is a phase I first-in-human 33 dose escalation study to evaluate the safety and feasibility of BHP01 in patents with relapsedrefractory SCLC who progressed after at least 1 platinum based chemotherapy regimenThis is a dose escalation and dose expansion study 12-21 patients with relapsedrefractory SCLC are planned to be enrolled Group Pre-AABC After the Dose-limiting toxicity DLT observation period of the related dose group finished16 patients are planned to enroll in dose expansion phase who was assign two groups withwithout bridge radiotherapy
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