A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

1. At least 19 years of age. 2. Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma. 3. At least one measurable or evaluable lesion. 4. Eastern Cooperative Oncology Group performance status 0 or 1. 5. A life expectancy of 3 months or more. 6. Acceptable hematological function, kidney, and liver function.

Exclusion Criteria:

1. Clinically significant cardiovascular disease within 6 months. 2. Primary malignant tumor other than the indications for this study. 3. The following diseases. 1. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks. 2. The New York Heart Association class III/IV. 3. Active hepatitis B virus or hepatitis C virus infection. 4. Human immunodeficiency virus positive. 5. Clinically significant symptoms or uncontrolled central nervous system metastasis. 4. Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study. 5. Received chemotherapy other than pre-conditioning within 4 weeks. 6. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks. 7. Hypersensitivity reactions to the study drug or excipients. 8. Hypersensitivity to cyclophosphamide or fludarabine. 9. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks. 10. Have previously received an allogeneic tissue/solid organ transplant. 11. Have administered other investigational drug or applied other investigational medical device within 4 weeks. 12. Pregnant or lactating female subjects. 13. Male subjects who did not agree to use contraception or to maintain abstinence

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GI Cell, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Korea, Republic of

The disease, disorder, syndrome, illness, or injury that is being studied.

Advanced Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Multiple Myeloma
Additional Details

This is a first-in-human, open-label, non-randomized, dose-escalation phase 1 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. 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. Patients will receive at least 2 cycles of GIC-102 (each cycle is 3 treatments at a frequency of once a week, and 28 days is defined as one cycle). After treatment period, patients will undergo follow up for survival every 8 weeks for up to 6 months.

Arms & Interventions


Experimental: GIC-102

On day -5, -4, and -3, patients receive cyclophosphamide 300 mg/m² and fludarabine 30mg/m² every 2 cycles On day 0, patients receive GIC-102 3 times at intervals of 1 week, and 28 days is defined as 1 cycle


Biological: - GIC-102 (Allogeneic NK cells)

Dose level 1: 1 x 10^9 cells Dose level 2: 3 x 10^9 cells Dose level 3: 1 x 10^10 cells

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Korea University Anam Hospital, Seoul, Korea, Republic of




Korea University Anam Hospital

Seoul, ,

Site Contact

Soo-Hyeon Lee, M.D Ph.D


+82 02-920-5690

Seoul Asan Medical center, Seoul, Korea, Republic of




Seoul Asan Medical center

Seoul, ,

Site Contact

Dok-Hyun Yoon, M.D Ph.D


+82 02-3010-5940

Seoul National University Hospital, Seoul, Korea, Republic of




Seoul National University Hospital

Seoul, ,

Site Contact

Jun-Shik Hong, M.D Ph.D


+82 02-6072-5206