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

• Sponsor: GI Cell, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05880043
• Collaborator: (none)
• Enrollment: 9
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 38.1
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors; Relapsed/Refractory Non-Hodgkin Lymphoma; Relapsed/Refractory Multiple Myeloma	Biological: GIC-102 (Allogeneic NK cells)	Phase 1

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 28, 2023
• Anticipated Primary Completion Date: Dec 30, 2025
• Anticipated Study Completion Date: Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GIC-102 On day -5, -4, and -3, patients receive cyclophosphamide 300 mg/m² and fludarabine 30mg/m² every 2 cycles On day 0, patients receive GIC-102 3 times at intervals of 1 week, and 28 days is defined as 1 cycle	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

Outcome Measures

Primary Outcome Measures

1. Dose-limiting toxicity assessment [Up to 1 month]

   To determine the maximum tolerated dose of allogeneic natural killer cells

2. Adverse event / Immune related adverse event [Through study completion, approximately 6 months]

   To determine the safety of GIC-102

Secondary Outcome Measures

1. Objective response rate and duration of response [Up to 6 months from the last patient enrolled]

   To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)

2. Progression free survival [Up to 6 months from the last patient enrolled]

   Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first

3. Overall survival [Up to 6 months from the last patient enrolled]

   Duration from start of study treatment to death (regardless of cause)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

4. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks

5. The New York Heart Association class III/IV

6. Active hepatitis B virus or hepatitis C virus infection

7. Human immunodeficiency virus positive

8. Clinically significant symptoms or uncontrolled central nervous system metastasis

9. 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

10. Received chemotherapy other than pre-conditioning within 4 weeks

11. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks

12. Hypersensitivity reactions to the study drug or excipients

13. Hypersensitivity to cyclophosphamide or fludarabine

14. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks

15. Have previously received an allogeneic tissue/solid organ transplant

16. Have administered other investigational drug or applied other investigational medical device within 4 weeks

17. Pregnant or lactating female subjects

18. Male subjects who did not agree to use contraception or to maintain abstinence

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GI-CELL	Gyeonggi-do		Korea, Republic of
2	Korea University Anam Hospital	Seoul		Korea, Republic of
3	Seoul Asan Medical center	Seoul		Korea, Republic of
4	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• GI Cell, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GI Cell, Inc.
• ClinicalTrials.gov Identifier: NCT05880043
• Other Study ID Numbers: GIC-102101
• First Posted: May 30, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of May 30, 2023