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

Primary Purpose

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

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GIC-102 (Allogeneic NK cells)
Sponsored by
GI Cell, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: 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 3 months or more Acceptable hematological function, kidney, and liver function Exclusion Criteria: Clinically significant cardiovascular disease within 6 months 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 Have administered other investigational drug or applied other investigational medical device within 4 weeks Pregnant or lactating female subjects Male subjects who did not agree to use contraception or to maintain abstinence

Sites / Locations

  • Korea University Anam HospitalRecruiting
  • Seoul Asan Medical centerRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GIC-102

Arm Description

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

Outcomes

Primary Outcome Measures

Dose-limiting toxicity assessment
To determine the maximum tolerated dose of allogeneic natural killer cells
Adverse event / Immune related adverse event
To determine the safety of GIC-102

Secondary Outcome Measures

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

Full Information

First Posted
April 24, 2023
Last Updated
June 15, 2023
Sponsor
GI Cell, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05880043
Brief Title
A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Cell, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GIC-102
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
GIC-102 (Allogeneic NK cells)
Intervention Description
Dose level 1: 1 x 10^9 cells Dose level 2: 3 x 10^9 cells Dose level 3: 1 x 10^10 cells
Primary Outcome Measure Information:
Title
Dose-limiting toxicity assessment
Description
To determine the maximum tolerated dose of allogeneic natural killer cells
Time Frame
Up to 1 month
Title
Adverse event / Immune related adverse event
Description
To determine the safety of GIC-102
Time Frame
Through study completion, approximately 6 months
Secondary Outcome Measure Information:
Title
Objective response rate and duration of response
Description
To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma)
Time Frame
Up to 6 months from the last patient enrolled
Title
Progression free survival
Description
Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first
Time Frame
Up to 6 months from the last patient enrolled
Title
Overall survival
Description
Duration from start of study treatment to death (regardless of cause)
Time Frame
Up to 6 months from the last patient enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 3 months or more Acceptable hematological function, kidney, and liver function Exclusion Criteria: Clinically significant cardiovascular disease within 6 months 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 Have administered other investigational drug or applied other investigational medical device within 4 weeks Pregnant or lactating female subjects Male subjects who did not agree to use contraception or to maintain abstinence
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Hyeon Lee, M.D Ph.D
Phone
+82 02-920-5690
Email
soohyeon_lee@korea.ac.kr
Facility Name
Seoul Asan Medical center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dok-Hyun Yoon, M.D Ph.D
Phone
+82 02-3010-5940
Email
dhyoon@amc.seoul.kr
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun-Shik Hong, M.D Ph.D
Phone
+82 02-6072-5206
Email
hongjblood@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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