Trial Title:
GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
NCT ID:
NCT05880043
Condition:
Advanced Solid Tumors
Relapsed/Refractory Non-Hodgkin Lymphoma
Relapsed/Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GIC-102
Description:
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days
is defined as 1 cycle
Arm group label:
Dose escalation phase: GIC-102 monotherapy
Intervention type:
Drug
Intervention name:
GIC-102
Description:
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days
is defined as 1 cycle
Arm group label:
Dose expansion phase: GIC-102 monotherapy
Summary:
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.
Detailed description:
This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase
1/2a 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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Soo-Hyeon Lee, M.D Ph.D
Phone:
+82 02-920-5690
Email:
soohyeon_lee@korea.ac.kr
Facility:
Name:
Seoul Asan Medical center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Dok-Hyun Yoon, M.D Ph.D
Phone:
+82 02-3010-5940
Email:
dhyoon@amc.seoul.kr
Facility:
Name:
Seoul Asan Medical center
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Not yet recruiting
Contact:
Last name:
Jae-Lyun Lee, M.D Ph.D
Phone:
+82-3010-5977
Email:
jaelyun@amc.seoul.kr
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Youngil Koh, M.D Ph.D
Phone:
+82 02-6072-5206
Email:
go01@snu.ac.kr
Start date:
April 28, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
GI Cell, Inc.
Agency class:
Industry
Source:
GI Cell, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05880043
