Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06228404
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-01-19
Brief Title:
Clinical Study of Safety and Efficacy of Enhanced PSMA CAR- T in Refractory CRPC
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
The Safety and Efficacy Evaluation of Enhanced Autologous PSMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory Castration Resistant Prostate Cancer
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 is one center single-arm open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer and the sample size is set to 7-18 subjects
Detailed Description:
This is one center single-arm open-label investigator initiated trial to assess the safety and efficacy of enhanced autologous PSMA chimeric antigen receptor T cells in the treatment for patients with refractory castration resistant prostate cancer and the sample size is set to 7-18 subjects Based on the 3 3 dose escalation design principle subjects will be divided into 3 groups from low dose to high dose in sequence Group A Group B Group C Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study
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