Clinical trial NCT05990920: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pathologically Confirmed Cancer Refractory to Conventional Therapy
Refractory Cancer
Metastatic Cancer
Recurrent Cancer
Solid Tumor, Adult
Solid Tumor
Advanced Cancer
Advanced Solid Tumor
Lead sponsor: NKGen Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
timeFrame: 4 weeks
measure: MTD and/or RP2D
timeFrame: 8 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Angeles Clinic and Research Institute
state: California
city: Santa Monica
country: United States
facility: Sarcoma Oncology Center
state: California
Study officials:
References: