Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963217
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-06-27
Brief Title:
Study of TBI-2001Autologous CD19 Specific Chimeric Antigen Receptor CAR Gene-transduced T Lymphocytes for Relapsed or Refractory CD19 B-cell Lymphoma CLLSLL
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Phase IIb Study of TBI-2001 for Patients With Relapsed or Refractory CD19 B-cell Lymphoma Chronic Lymphocytic Leukemia CLL Small Lymphocytic Lymphoma SLL
Status:
RECRUITING
Status Verified Date:
2024-08
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 Phase 11b open-label dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor CAR TBI-2001 for relapsed or refractory CD19 B-cell lymphoma Chronic Lymphocytic Leukemia CLL Small Lymphocytic Lymphoma SLL
Detailed Description:
TBI-2001 is a next-generation CAR-T product including costimulatory sequences that lead to the activation of cytokine-related JAKSTAT signaling pathways This is a first-in-human study of TBI-2001 and will follow a 33 design of dose-escalation cohorts Additional subjects will be treated with TBI-2001 at the determined recommended phase 2 dose RP2D following cyclophosphamide and fludarabine pre-treatment Long-term follow-up is conducted for 5 years following the infusion of TBI-2001
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