Ignite Creation Date:
2024-07-17 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501183
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
Sponsor:
Shanghai Pudong Hospital
Organization:
Shanghai Pudong Hospital
Study Overview
Official Title:
Exploratory Study to Evaluate the Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
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 single-arm open-label exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors
Detailed Description:
This study will include two parts dose escalation phase accelerated titration and 33 design followed by a dose expansion phase
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by Anti-CDH17 CAR-T cell injection
The dose escalation phase will determine the maximum tolerated dose MTD of Anti-CDH17 CAR-T cell injection Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-CDH17 CAR-T cell injection and establish recommended phase 2 dose RP2D
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by Anti-CDH17 CAR-T cell injection
The dose escalation phase will determine the maximum tolerated dose MTD of Anti-CDH17 CAR-T cell injection Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-CDH17 CAR-T cell injection and establish recommended phase 2 dose RP2D
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