Clinical trial NCT05880043: GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Relapsed/Refractory Non-Hodgkin Lymphoma
Relapsed/Refractory Multiple Myeloma
Lead sponsor: GI Cell, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Dose-limiting toxicity assessment (dose escalation phase)
timeFrame: Up to 4 weeks
measure: Adverse event / Immune related adverse event
timeFrame: through study completion, an average of 1 year
measure: Objective Response Rate (ORR) (dose expansion phase)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Objective response rate (ORR) (dose escalation phase)
timeFrame: through study completion, an average of 1 year
measure: Progression free survival (PFS)
timeFrame: Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase)
measure: Overall survival (OS)
timeFrame: Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase)
measure: Duration of response (DOR)
timeFrame: Through study completion
measure: Disease Control Rate (DCR)
timeFrame: through study completion, an average of 1 year
measure: PK Profile (dose expansion phase) -Cmax
timeFrame: up to 6 months
measure: PK Profile (dose expansion phase) - Tmax
timeFrame: up to 6 months
measure: PK Profile (dose expansion phase) - AUC
timeFrame: up to 6 months
Other outcomes:
measure: PK Profile (dose escalation phase) -Cmax
timeFrame: up to 6 months
measure: PK Profile (dose escalation phase) - Tmax
timeFrame: up to 6 months
measure: PK Profile (dose escalation phase) - AUC
timeFrame: up to 6 months
measure: Immune Profile
timeFrame: through study completion, an average of 1 year
measure: Alloantibody Identification
timeFrame: through study completion, an average of 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: