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Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy

Primary Purpose

Pathologically Confirmed Cancer Refractory to Conventional Therapy, Refractory Cancer, Metastatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SNK02
Sponsored by
NKGen Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathologically Confirmed Cancer Refractory to Conventional Therapy

Eligibility Criteria

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

Inclusion Criteria: Pathologically confirmed diagnosis of refractory cancer that has failed at least prior line of conventional standard of care therapy. Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard curative or beneficial treatments are no longer effective. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ≥ 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). ≥ 2 weeks since prior palliative radiotherapy. Complete recovery to baseline or Grade 1 NCI CTCAE v5.0 from AE of prior surgery, radiotherapy, endocrine therapy, and other therapy as applicable, with exception of grade 2 alopecia from prior chemotherapy. Adequate bone marrow function: Neutrophils: ≥ 1.5 K/µL without colony-stimulating factor support Platelet Count: ≥ 100 K/µL Hemoglobin: ≥ 9.0 g/dL without need for hematopoietic growth factor or transfusion support No ongoing transfusion requirements Adequate hepatic function: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply to patients with Gilbert's syndrome Serum albumin ≥ 3.0 g/dL ALT and AST ≤ 2.5 × ULN, unless hepatic metastases are present then < 5 x ULN Adequate renal function with creatinine ≤ 2.0 mg/dL. Coagulation: INR or aPTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Adequate pulmonary function as assessed by pulse oximetry (>92% oxygen saturation on room air). Negative pregnancy test for women of childbearing potential (i.e., all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization) and agree to use of effective contraception (hormonal or barrier method of birth control) during study. Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Exclusion Criteria: Pregnant and/or lactating females. Life expectancy of less than three months. Currently being treated by "biological therapy" as defined by the National Cancer Institute (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet) Examples include checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, CAR-T therapy, and natural killer (NK) cell therapy. Participants that are actively positive for COVID. Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy, with exception to the following: intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Prior clinical trial requiring participant to receive an investigational drug within four weeks of enrollment. Live vaccine within 30 days prior to enrollment. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Mental or psychological illness preventing cooperation with treatment, efficacy evaluations. Participants who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.

Sites / Locations

  • Sarcoma Oncology CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort 1

Arm Description

SNK02 will be administered as an IV infusion weekly for 8 weeks.

Outcomes

Primary Outcome Measures

Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
MTD and/or RP2D
Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs

Secondary Outcome Measures

Full Information

First Posted
July 28, 2023
Last Updated
September 5, 2023
Sponsor
NKGen Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05990920
Brief Title
Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy
Official Title
A Phase 1, Open-Label, Dose Escalation Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Participants With Pathologically Confirmed Cancer Refractory to Conventional Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NKGen Biotech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to test SNK02 in participants with pathologically confirmed cancer that is refractory to conventional therapy. The main questions it aims to answer are: Is SNK02 safety and tolerable when administered weekly as an intravenous infusion What is the maximum dose that is tolerated of SNK02 Participants will be administered SNK02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical safety data for the treatment of cancer with allogeneic NK cells as a monotherapy treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathologically Confirmed Cancer Refractory to Conventional Therapy, Refractory Cancer, Metastatic Cancer, Recurrent Cancer, Solid Tumor, Adult, Solid Tumor, Advanced Cancer, Advanced Solid Tumor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
SNK02 will be administered as an IV infusion weekly for 8 weeks.
Intervention Type
Biological
Intervention Name(s)
SNK02
Intervention Description
SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
Description
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
Time Frame
4 weeks
Title
MTD and/or RP2D
Description
Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02
Time Frame
8 weeks
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Description
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed diagnosis of refractory cancer that has failed at least prior line of conventional standard of care therapy. Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard curative or beneficial treatments are no longer effective. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ≥ 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). ≥ 2 weeks since prior palliative radiotherapy. Complete recovery to baseline or Grade 1 NCI CTCAE v5.0 from AE of prior surgery, radiotherapy, endocrine therapy, and other therapy as applicable, with exception of grade 2 alopecia from prior chemotherapy. Adequate bone marrow function: Neutrophils: ≥ 1.5 K/µL without colony-stimulating factor support Platelet Count: ≥ 100 K/µL Hemoglobin: ≥ 9.0 g/dL without need for hematopoietic growth factor or transfusion support No ongoing transfusion requirements Adequate hepatic function: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply to patients with Gilbert's syndrome Serum albumin ≥ 3.0 g/dL ALT and AST ≤ 2.5 × ULN, unless hepatic metastases are present then < 5 x ULN Adequate renal function with creatinine ≤ 2.0 mg/dL. Coagulation: INR or aPTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy. Adequate pulmonary function as assessed by pulse oximetry (>92% oxygen saturation on room air). Negative pregnancy test for women of childbearing potential (i.e., all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization) and agree to use of effective contraception (hormonal or barrier method of birth control) during study. Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Exclusion Criteria: Pregnant and/or lactating females. Life expectancy of less than three months. Currently being treated by "biological therapy" as defined by the National Cancer Institute (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet) Examples include checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, CAR-T therapy, and natural killer (NK) cell therapy. Participants that are actively positive for COVID. Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy, with exception to the following: intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Prior clinical trial requiring participant to receive an investigational drug within four weeks of enrollment. Live vaccine within 30 days prior to enrollment. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. Mental or psychological illness preventing cooperation with treatment, efficacy evaluations. Participants who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
949-396-6830
Email
trials@nkgenbiotech.com
Facility Information:
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Chua, MD
Phone
310-552-9999
First Name & Middle Initial & Last Name & Degree
Sant Chawla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy

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