Actively Recruiting
GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
Led by GI Cell, Inc. · Updated on 2024-07-09
50
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years of age
- Diagnosed with advanced solid tumors, relapsed or refractory non-Hodgkin lymphoma, or multiple myeloma
- Have at least one measurable or evaluable tumor lesion
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of 12 weeks or more
- Acceptable blood, kidney, and liver function
- Willing and able to sign informed consent form
You will not qualify if you...
- Clinically significant cardiovascular disease within the past 24 weeks
- Have a primary malignant tumor other than the study indications
- Have severe infection or uncontrolled active infection requiring systemic antibiotics or antivirals within 4 weeks
- New York Heart Association class III or IV heart failure
- Active hepatitis B or hepatitis C infection
- HIV positive
- Clinically significant or uncontrolled central nervous system metastasis
- Diagnosed with immunodeficiency or need systemic corticosteroids or other immunosuppressants within 2 weeks or during the study
- Received chemotherapy other than pre-conditioning within 4 weeks
- Major surgery within 4 weeks or minor surgery within 2 weeks before study
- Allergic reactions to the study drug or its ingredients
- Allergic to cyclophosphamide or fludarabine
- Received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
- Previously received allogeneic tissue or solid organ transplant
- Used other investigational drugs or devices within 4 weeks
- Pregnant or breastfeeding women
- Male subjects not agreeing to use contraception or abstain
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
2
Seoul Asan Medical center
Seoul, South Korea
Actively Recruiting
3
Seoul Asan Medical center
Seoul, South Korea
Not Yet Recruiting
4
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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