Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05880043
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2023-04-24
Brief Title:
GIC-102 Intravenous Allogeneic NK Cells in Subjects With Advanced Solid Cancers and RR Hematologic Malignancies
Sponsor:
GI Cell Inc
Organization:
GI Cell Inc
Study Overview
Official Title:
An Open-label Multi-center Dose-escalation and Expansion Phase 12a Study to Evaluate the Safety Tolerability PKPD and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors RR Non-Hodgkin Lymphoma and Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-06
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 first-in-human trial to investigate the safety tolerability pharmacokinetics pharmacodynamics and antitumor effects of GIC-102 in patients with advanced solid tumors relapsedrefractory non-hodgkin lymphoma and multiple myeloma
Detailed Description:
This is a first-in-human open-label non-randomized dose-escalation and expansion phase 12a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors relapsedrefractory non-hodgkin lymphoma and multiple myeloma
This study will comprise two phases
GIC-102 monotherapy dose escalation Phase
GIC-102 monotherapy dose expansion phase
GIC-102 is an off-the-shelf allogeneic natural killer cells isolated from non-HLA-related healthy donor Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells
This study will comprise two phases
GIC-102 monotherapy dose escalation Phase
GIC-102 monotherapy dose expansion phase
GIC-102 is an off-the-shelf allogeneic natural killer cells isolated from non-HLA-related healthy donor Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells
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