Pathologically Confirmed Cancer Refractory to Conventional TherapyPhase 1NCT05990920
Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy
A Phase 1 study testing SNK02 in people with Pathologically Confirmed Cancer Refractory to Conventional Therapy and Refractory Cancer, run by NKGen Biotech, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathologically Confirmed Cancer Refractory to Conventional Therapy, Refractory Cancer, Metastatic Cancer
- What is being tested?
- SNK02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2023to 12 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Angeles Clinic and Research Institute
Los Angeles, California, 90025
Sarcoma Oncology Center
Santa Monica, California, 90403
About this study
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
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
- Being tested
- SNK02
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNK02Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | SNK02 will be administered as an IV infusion weekly for 8 weeks. Receives: Biological: SNK02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
MTD and/or RP2D
Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start23 Aug 2023
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologically Confirmed Cancer Refractory to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NKGen Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990920
- Sponsor's protocol ID
- SNK02-202
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05990920
- Acronym / sponsor ID
- SNK02-202
- Conditions
- Pathologically Confirmed Cancer Refractory to Conventional Therapy, Refractory Cancer, Metastatic Cancer, Recurrent Cancer, Solid Tumor, Adult, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NKGen Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: SNK02SNK02 will be administered as an IV infusion weekly for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNK02SNK02 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. | Biological | Cohort 1 |
Primary outcome
Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
Time frame: 4 weeks
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
MTD and/or RP2D
Time frame: 8 weeks
Determine the maximum tolerated dose or the ready for Phase 2 dose of SNK02
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 12 weeks
Evaluate the safety and tolerability of SNK02 assessed by labs, PE and AEs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNK02 in people with Pathologically Confirmed Cancer Refractory to Conventional Therapy and Refractory Cancer, run by NKGen Biotech, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.