Using GIC-102 NK cells to treat advanced solid tumors and blood cancers
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
This study is testing a new cell therapy called GIC-102 to see if it can safely help people with advanced solid tumors and certain blood cancers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | GI Cell, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 4 sites (Seoul and 3 other locations) |
| Trial ID | NCT05880043 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of GIC-102, an allogeneic natural killer (NK) cell therapy, in patients with advanced solid tumors and relapsed/refractory hematologic malignancies. It consists of a dose-escalation phase to determine the maximum tolerated dose followed by a dose expansion phase. The trial is open-label and non-randomized, focusing on evaluating pharmacokinetics, pharmacodynamics, and antitumor effects. Participants will receive GIC-102 monotherapy to assess its potential as a treatment option for these challenging cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with advanced solid tumors or relapsed/refractory non-Hodgkin lymphoma or multiple myeloma.
Not a fit: Patients with significant cardiovascular disease, active infections, or other primary malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are difficult to treat.
How similar studies have performed: Other studies using NK cell therapies have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full 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 12 weeks or more 6. Acceptable hematological function, kidney, and liver function 7. Subjects who sign on an informed consent form willingly Exclusion Criteria: 1. Clinically significant cardiovascular disease within 24 weeks 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
Where this trial is running
Seoul and 3 other locations
- Korea University Anam Hospital — Seoul, South Korea (Recruiting)
- Seoul Asan Medical center — Seoul, South Korea (Recruiting)
- Seoul Asan Medical center — Seoul, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.