Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800977
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-24
Brief Title:
A Study of C-CAR039 Prizloncabtagene Autoleucel in Patients With RelapsedRefractory Large B-Cell Lymphoma
Sponsor:
Cellular Biomedicine Group Ltd
Organization:
Cellular Biomedicine Group Ltd
Study Overview
Official Title:
A Phase 1b2 Study of a Anti-CD19CD20 Bispecific CAR-T Therapy C-CAR039Prizloncabtagene Autoleucel in Patients With RelapsedRefractory Large B-Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-03
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:
ELEVATION
Brief Summary:
This is a multicenter single arm open-label study The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel Prizlon-cel and establish the recommended Phase 2 dose RP2D Phase 1b and to evaluate the efficacy of Prizlon-cel Phase 2 in patients with relapsed or refractory large b-cell lymphoma LBCL
Detailed Description:
The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel It includes two phases Phase 1b and Phase 2 In Phase 1b study RP2D will be determined The selected dose will be further evaluated in the Phase 2 study The study includes the following sequential procedures Screening Apheresis and CAR-T manufacturing Baseline Lymphodepletion CAR-T infusion DLT period Phase 1b and Follow-up Visit Subjects will be followed for at least 2 years after Prizlon-cel infusion with up to 15 years long-term follow-up on a separate 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