Overview

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

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NKGen Biotech, Inc.
NKMax America, Inc.
Treatments:
Avelumab
Pembrolizumab
Criteria
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

- 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

- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN

- International normalized ratio (INR) ≤ 1.5 x ULN

- Adequate renal function with creatinine ≤ 2.0 mg/dL.

- Negative pregnancy test for women of childbearing potential and use of effective
contraception (hormonal or barrier method of birth control) during study.

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.

- 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.