Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05990621
Status:
RECRUITING
Last Update Posted:
2023-08-14
First Post:
2023-08-07
Brief Title:
Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urologic Neoplasms
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
A Single-arm Open-label Dose-escalationExpansion Early-phase Clinical Study of Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urological Neoplasms
Status:
RECRUITING
Status Verified Date:
2023-08
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 tolerability and preliminary efficacy of Anti-CD70 CAR-T cell injection in patients with CD70-positive Advanced Urologic Neoplasms
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 CAR-T cell injection
The dose escalation phase will determine the maximum tolerated dose MTD of Anti-CD70 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-CD70 CAR-T cell injection and establish recommended phase 2 dose RP2D
The dose escalation phase will determine the maximum tolerated dose MTD of Anti-CD70 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-CD70 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