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

NCT05880043 | Recruiting Phase 1

• 1 other identifier: GIC-102101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumors; Relapsed/Refractory Non-Hodgkin Lymphoma; Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicity assessment (dose escalation phase)

  To determine the maximum tolerated dose of allogeneic natural killer cells

  Up to 4 weeks

• Adverse event / Immune related adverse event

  To determine the safety of GIC-102

  through study completion, an average of 1 year

• Objective Response Rate (ORR) (dose expansion phase)

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

  through study completion, an average of 1 year

Secondary Outcomes (8)

• Objective response rate (ORR) (dose escalation phase)

  through study completion, an average of 1 year

• Progression free survival (PFS)

  Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase)

• Overall survival (OS)

  Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase)

• Duration of response (DOR)

  Through study completion

• Disease Control Rate (DCR)

  through study completion, an average of 1 year

Other Outcomes (5)

• PK Profile (dose escalation phase) -Cmax

  up to 6 months

• PK Profile (dose escalation phase) - Tmax

  up to 6 months

• PK Profile (dose escalation phase) - AUC

  up to 6 months

Study Arms (2)

Dose escalation phase: GIC-102 monotherapy

EXPERIMENTAL

* 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

Drug: GIC-102

Dose expansion phase: GIC-102 monotherapy

EXPERIMENTAL

\- Dose level: RP2D

Drug: GIC-102

Interventions

GIC-102 DRUG

GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle

Dose escalation phase: GIC-102 monotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 19 years of age
• Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma
• At least one measurable or evaluable lesion
• Eastern Cooperative Oncology Group performance status 0 or 1
• A life expectancy of 12 weeks or more
• Acceptable hematological function, kidney, and liver function
• Subjects who sign on an informed consent form willingly

You may not qualify if:

• Clinically significant cardiovascular disease within 24 weeks
• Primary malignant tumor other than the indications for this study
• The following diseases
• Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks
• The New York Heart Association class III/IV
• Active hepatitis B virus or hepatitis C virus infection
• Human immunodeficiency virus positive
• Clinically significant symptoms or uncontrolled central nervous system metastasis
• 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
• Received chemotherapy other than pre-conditioning within 4 weeks
• Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks
• Hypersensitivity reactions to the study drug or excipients
• Hypersensitivity to cyclophosphamide or fludarabine
• Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
• Have previously received an allogeneic tissue/solid organ transplant

Sponsors & Collaborators

• GI Cell, Inc.: lead

Study Sites (4)

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Seoul Asan Medical center

Seoul, South Korea

RECRUITING

Seoul Asan Medical center

Seoul, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Multiple Myeloma

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 30, 2023
• Study Start: April 28, 2023
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)