GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
NCT ID: NCT05880043
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2023-04-28
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose escalation phase: GIC-102 monotherapy
* 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
GIC-102
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
Dose expansion phase: GIC-102 monotherapy
\- Dose level: RP2D
GIC-102
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
Interventions
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GIC-102
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
GIC-102
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
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GI Cell, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Facility Contacts
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Other Identifiers
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GIC-102101
Identifier Type: -
Identifier Source: org_study_id
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