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Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients With Pathologically Confirmed Cancer Refractory to Conventional Therapy

NCT03941262•NKGen Biotech, Inc.

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary written informed consent signed by patient, obtained prior to study enrollment.
•Males and females ages 18 to 75 years, inclusive.
•Pathologically confirmed diagnosis of refractory cancer that has failed three or more prior lines 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 \<2.
•At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational).
•At least 2 weeks since prior palliative radiotherapy.
•Adequate bone marrow function:
•* Neutrophils: 2.0-8.0 K/uL
•* Platelet Count: 140-440 K/uL
+9 more criteria

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 (example: checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, Bacillus Calmette-Guerin (BCG), chimeric antigen receptor T cell therapy (CAR-T), and natural killer cell therapy).
•Patients tested positive for hepatitis B and/or C surface antigen.
•High fever or any active or unresolved infection, including human immunodeficiency virus (HIV) positive.
•Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy.
•Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment.
•Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation.
•Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process.
•Subjects who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.
+3 more criteria

Locations (1)

Sarcoma Oncology Research Center

Santa Monica, California, United States

Key Dates

Start Date

July 15, 2019

Primary Completion Date

February 17, 2023

Completion Date

February 17, 2023

Last Updated

November 13, 2023

Enrollment

ACTUAL participants

Conditions

Refractory CancerMetastatic CancerRecurrent CancerUnresectable CarcinomaSolid Tumor, AdultAdvanced CancerAdvanced Solid Tumor

Interventions

SNK01

BIOLOGICAL

Avelumab

DRUG

Pembrolizumab

DRUG

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

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RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

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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: November 13, 2023Data 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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Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Inclusion Criteria

Exclusion Criteria

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Y-NM600 in Patients Receiving Anti-PD-1 or Anti-PD-L1 for Metastatic Cancer

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STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study