Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05207722
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-16
First Post:
2022-01-12
Brief Title:
CYNK-101 in Combination With Trastuzumab and Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction GGEJ Adenocarcinoma
Sponsor:
Celularity Incorporated
Organization:
Celularity Incorporated
Study Overview
Official Title:
A Phase IIIa Open Label Non-Randomized Multicenter Study of CYNK-101 in Combination With Trastuzumab and Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction GGEJ Aenocarcinoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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 study will find the maximum tolerated dose MTD of CYNK-101 which contains Natural Killer NK cells derived from human placental CD34 cells and culture-expanded CYNK-101 will be administered as first-line treatment following induction therapy consisting of Pembrolizumab Trastuzumab and a Fluoropyrimidine Platinum based Chemotherapy regimen Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3 or IHC 2 with a positive fluorescent in-situ hybridization FISH or FISH alone The safety of this treatment will be evaluated and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction GGEJ Adenocarcinoma
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