Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Relapsed/Refractory Multiple Myeloma | — | UNRESOLVED | — |
| Relapsed/Refractory Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GIC-102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation phase: GIC-102 monotherapy
- description
- * Low Dose level 1: 1 x 10\^9 cells * Mid Dose level 2: 3 x 10\^9 cells * High Dose level 3: 1 x 10\^10 cells
- interventionNames
- Drug: GIC-102
- type
- EXPERIMENTAL
- label
- Dose expansion phase: GIC-102 monotherapy
- description
- \- Dose level: RP2D
- interventionNames
- Drug: GIC-102
Primary outcomes (3)
- measure
- Dose-limiting toxicity assessment (dose escalation phase)
- timeFrame
- Up to 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available