Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04696432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-31
First Post:
2020-11-30
Brief Title:
A Study of C-CAR039 Treatment in Subjects With rr NHL SubjectsNon-Hodgkins Lymphoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed andor Refractory NHL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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-center open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed andor refractory B-NHL patients
Detailed Description:
This is a single-arm open label phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsedrefractory B-cell Non-Hodgkins Lymphoma 10 patients are planned to be enrolled Following consent enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039 Following manufacture of the drug product subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion All subjects who have received C-CAR039 infusion will be followed for up to 24 months
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