NCT03941262

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

November 13, 2023

Status Verified

July 1, 2023

Enrollment Period

3.6 years

First QC Date

May 3, 2019

Last Update Submit

November 8, 2023

Conditions

Refractory CancerMetastatic CancerRecurrent CancerUnresectable CarcinomaSolid Tumor, AdultAdvanced CancerAdvanced Solid Tumor

Keywords

Natural killer cellNK cellExpanded natural killer cellImmunotherapyCancerMetastatic cancerAdvanced solid tumorRefractory cancerRecurrent cancerUnresectable carcinomaSolid tumorNeoplasms

Outcome Measures

Primary Outcomes (1)

  • To assess the safety profile

    Assessed by the incidence and severity of dose limiting toxicity (DLT) and other adverse events graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 5.0, or the cytokine release syndrome revised grading system.

    Up to 6 months

Secondary Outcomes (3)

  • To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer

    Up to 12 months

  • To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer

    Up to 12 months

  • To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer

    Up to 12 months

Study Arms (5)

Cohort 1 - Low dose SNK01

EXPERIMENTAL

SNK01 (low dose) administered once a week for five weeks.

Biological: SNK01

Cohort 2 - Medium dose SNK01

EXPERIMENTAL

SNK01 (medium dose) administered once a week for five weeks.

Biological: SNK01

Cohort 3 - High dose SNK01

EXPERIMENTAL

SNK01 (high dose) administered once a week for five weeks.

Biological: SNK01

Cohort 4 - SNK01 with avelumab

EXPERIMENTAL

SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.

Biological: SNK01Drug: Avelumab

Cohort 4 - SNK01 with pembrolizumab

EXPERIMENTAL

SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.

Biological: SNK01Drug: Pembrolizumab

Interventions

SNK01BIOLOGICAL

Patient-specific ex vivo expanded autologous natural killer cells

Cohort 1 - Low dose SNK01Cohort 2 - Medium dose SNK01Cohort 3 - High dose SNK01Cohort 4 - SNK01 with avelumabCohort 4 - SNK01 with pembrolizumab
AvelumabDRUG

Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).

Also known as: Bavencio
Cohort 4 - SNK01 with avelumab
PembrolizumabDRUG

Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).

Also known as: Keytruda
Cohort 4 - SNK01 with pembrolizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Hemoglobin: 10.0-18.0 g/dL
  • No ongoing transfusion requirements
  • Adequate hepatic function:
  • Serum total bilirubin \< 1.5 x upper limit of normal (ULN)
  • Serum albumin ≥ 3.0 g/dL
  • +4 more criteria

You may not qualify if:

  • 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.
  • Adult subjects who lack capacity to consent for themselves and for whom consent must be provided by a legally authorized representative.
  • For SNK01+avelumab arm only: Subjects with prior hypersensitivity to avelumab or its excipients, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
  • For SNK01+avelumab arm only: Subjects with a significant immune-mediated adverse event due to a prior checkpoint inhibitor immunotherapy that led to permanent discontinuation of the therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm MetastasisRecurrence

Interventions

avelumabpembrolizumab

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Paul Chang, MPH

    NKGen Biotech, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 7, 2019

Study Start

July 15, 2019

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

November 13, 2023

Record last verified: 2023-07

Locations

US(1)