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

NCT05990920 | Completed Phase 1 FDA Drug

• 1 other identifier: SNK02-202
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Pathologically Confirmed Cancer Refractory to Conventional Therapy; Refractory Cancer; Metastatic Cancer; Recurrent Cancer; Solid Tumor, Adult; Solid Tumor; Advanced Cancer; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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

  4 weeks

• MTD and/or RP2D

  Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02

  8 weeks

• 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

  12 weeks

Study Arms (1)

Cohort 1

EXPERIMENTAL

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

Biological: SNK02

Interventions

SNK02 BIOLOGICAL

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.

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 (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.

Sponsors & Collaborators

• NKGen Biotech, Inc.: lead

Study Sites (2)

Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Recurrence

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 14, 2023
• Study Start: August 23, 2023
• Primary Completion: April 12, 2024
• Study Completion: April 12, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)