A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma

Advanced Solid Tumors Clinical Trial

Official title:

Open-label, Multi-center, Dose-escalation Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of GIC-102 in Patients With Advanced Solid Tumors, R/R Non-Hodgkin Lymphoma, and Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880043
• Other study ID #: GIC-102101
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: GI Cell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a first-in-human, open-label, non-randomized, dose-escalation phase 1 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. 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. Patients will receive at least 2 cycles of GIC-102 (each cycle is 3 treatments at a frequency of once a week, and 28 days is defined as one cycle). After treatment period, patients will undergo follow up for survival every 8 weeks for up to 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 3 months or more

6. Acceptable hematological function, kidney, and liver function

Exclusion Criteria:

1. Clinically significant cardiovascular disease within 6 months

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma
• Relapsed/Refractory Non-Hodgkin Lymphoma

Intervention

Biological:
• GIC-102 (Allogeneic NK cells)
Dose level 1: 1 x 10^9 cells Dose level 2: 3 x 10^9 cells Dose level 3: 1 x 10^10 cells

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul Asan Medical center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GI Cell, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity assessment	To determine the maximum tolerated dose of allogeneic natural killer cells	Up to 1 month
Primary	Adverse event / Immune related adverse event	To determine the safety of GIC-102	Through study completion, approximately 6 months
Secondary	Objective response rate and duration of response	To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)	Up to 6 months from the last patient enrolled
Secondary	Progression free survival	Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first	Up to 6 months from the last patient enrolled
Secondary	Overall survival	Duration from start of study treatment to death (regardless of cause)	Up to 6 months from the last patient enrolled