Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197178
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-11-20
Brief Title:
A Study of LCAR-G08 in Subjects With Advanced Gastrointestinal Tumors Expressing Guanylyl Cyclase C GCC
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
A Phase 1 Open-Label Study Evaluating the Safety Tolerability and Efficacy of LCAR-G08 a Chimeric Antigen Receptor CAR-T Cell Therapy Targeting Guanylyl Cyclase C GCC in Subjects With Advanced Gastrointestinal Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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 is a phase 1 single-arm open-label dose escalation and expansion study of LCAR-G08 in adult subjects with advanced gastrointestinal tumors expressing guanylyl cyclase C GCC
Detailed Description:
This is a phase 1 single-arm open-label dose escalation and expansion study to evaluate the safety tolerability pharmacokinetics and anti-tumor efficacy profiles of the cell-based LCAR- G08 in subjects with guanylyl cyclase C GCC-positive advanced gastrointestinal tumors Subjects who meet the eligibility criteria will receive LCAR-G08 infusion The study will include the following sequential phases screening pre-treatment cell product preparation lymphodepleting chemotherapy treatment and follow up
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