Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05880043

GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

An Open-label, Multi-center, Dose-escalation and Expansion, Phase 1/2a Study to Evaluate the Safety, Tolerability, PK/PD, and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors, R/R Non-Hodgkin Lymphoma, and Multiple Myeloma

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
GI Cell, Inc. · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.

Detailed description

This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors, relapsed/refractory 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.

Conditions

Interventions

TypeNameDescription
DRUGGIC-102GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
DRUGGIC-102GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle

Timeline

Start date
2023-04-28
Primary completion
2025-12-30
Completion
2026-06-30
First posted
2023-05-30
Last updated
2024-07-09

Locations

4 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05880043. Inclusion in this directory is not an endorsement.