Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218408
Status:
WITHDRAWN
Last Update Posted:
2023-02-16
First Post:
2022-01-18
Brief Title:
CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type
Sponsor:
Celularity Incorporated
Organization:
Celularity Incorporated
Study Overview
Official Title:
A Phase IIIa Open Label Multicenter Non-Randomized Trial to Assess the Safety and Efficacy of CYNK-001in Combination With Recombinant Human Interleukin-2 in Adults With Recurrent Resection Eligible IDH1 Wild-type Glioblastoma
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrolled subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYNK001GBM02
Brief Summary:
A Phase 12a Open Label Multicenter Non-Randomized Trial to Assess the Safety and Efficacy of CYNK-001 in Combination with Recombinant Human Interleukin-2 in Adults with Recurrent Resection Eligible IDH1 wild-type Glioblastoma For phase I portion the study objectives to assess the safety and feasibility CYNK-001 in combination with rhIL2 of Intravenous IV infusion and Intracavitary IC administrations following tumor resection and to establish a maximum tolerated dose MTD and a Recommended Phase 2a Dose RP2D for IV and IC CYNK-001 administration For Phase IIa to evaluate efficacy and safety of CYNK-001 administrations in recurrent GBM as measured by Progression Free Survival at 6 months PFS6M
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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