GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors; Relapsed/Refractory Non-Hodgkin Lymphoma; Relapsed/Refractory Multiple Myeloma
• Interventions: Drug: GIC-102

• Registration Number: NCT05880043
• Lead Sponsor: GI Cell, Inc.

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study Start: 2023-04-28
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-12-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalation phase: GIC-102 monotherapy	GIC-102	* Low Dose level 1: 1 x 10\^9 cells * Mid Dose level 2: 3 x 10\^9 cells * High Dose level 3: 1 x 10\^10 cells
Dose expansion phase: GIC-102 monotherapy	GIC-102	- Dose level: RP2D

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity assessment (dose escalation phase)	Up to 4 weeks	To determine the maximum tolerated dose of allogeneic natural killer cells
Adverse event / Immune related adverse event	through study completion, an average of 1 year	To determine the safety of GIC-102
Objective Response Rate (ORR) (dose expansion phase)	through study completion, an average of 1 year	To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)

Secondary Outcome Measures

Name	Time	Method
PK Profile (dose expansion phase) - Tmax	up to 6 months
Objective response rate (ORR) (dose escalation phase)	through study completion, an average of 1 year	To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)
Overall survival (OS)	Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase)	Duration from start of study treatment to death (regardless of cause)
Duration of response (DOR)	Through study completion	Time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause
PK Profile (dose expansion phase) -Cmax	up to 6 months
PK Profile (dose expansion phase) - AUC	up to 6 months
Progression free survival (PFS)	Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase)	Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first
Disease Control Rate (DCR)	through study completion, an average of 1 year	Percentage of patients who have achieved CR, PR and stable disease (SD)

Trial Locations

Locations (3)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul Asan Medical center; 🇰🇷 Seoul, Korea, Republic of

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of