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GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT05880043•GI Cell, Inc.

View on ClinicalTrials.gov

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

Locations (4)

Korea University Anam Hospital

Seoul, South Korea

Seoul Asan Medical center

Seoul, South Korea

Seoul Asan Medical center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

April 28, 2023

Primary Completion Date

December 30, 2025

Completion Date

June 30, 2026

Last Updated

July 9, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Solid TumorsRelapsed/Refractory Non-Hodgkin LymphomaRelapsed/Refractory Multiple Myeloma

Interventions

GIC-102

DRUG

GIC-102

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE1/PHASE2

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

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Relapsed/Refractory Multiple Myeloma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

A Study of ASP1002 in Adults for Treatment of Solid Tumors

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma