RecruitingPhase 1Phase 2NCT05880043

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


Sponsor

GI Cell, Inc.

Enrollment

50 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests GIC-102, a type of treatment using natural killer (NK) cells from a healthy donor, given intravenously to patients with advanced solid cancers (like lung, breast, or colon cancer) or blood cancers (like non-Hodgkin lymphoma or multiple myeloma) that have not responded to prior treatments. NK cells are immune cells that naturally attack cancer. **You may be eligible if...** - You are 19 or older with advanced solid cancer, relapsed/refractory non-Hodgkin lymphoma, or multiple myeloma - You have at least one measurable or evaluable tumor - Your general health is good (ECOG 0–1) with a life expectancy of at least 12 weeks - Your blood, kidney, and liver function are acceptable **You may NOT be eligible if...** - You have significant heart disease or active hepatitis B, C, or HIV - You have had a prior organ transplant or allogeneic cell therapy within 6 months - You are on immunosuppressants or have an immunodeficiency - You had major surgery within 4 weeks or minor surgery within 2 weeks - You are pregnant or breastfeeding - You have a known allergy to the study drug or the chemotherapy prep medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGIC-102

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

DRUGGIC-102

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


Locations(4)

Korea University Anam Hospital

Seoul, South Korea

Seoul Asan Medical center

Seoul, South Korea

Seoul Asan Medical center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT05880043


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