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CAR T-cell Therapy
NK Cells (SNK02) for Refractory Cancer
Phase 1
Waitlist Available
Research Sponsored by NKGen Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will test the safety of administering allogeneic NK cells (SNK02) to cancer patients who haven't responded to conventional treatments. Participants will receive weekly doses of SNK02 for 8 weeks for evaluation.
Who is the study for?
This trial is for adults with advanced cancers that haven't responded to standard treatments. They should be relatively healthy otherwise, with good liver, kidney, and bone marrow function, not pregnant or breastfeeding, able to use birth control if needed, and have no severe heart issues or autoimmune diseases requiring strong medication.Check my eligibility
What is being tested?
The study tests SNK02—a treatment involving natural killer (NK) cells given through an IV once a week for two months. It aims to find out how safe it is and the highest dose patients can take without serious side effects.See study design
What are the potential side effects?
While specific side effects of SNK02 are being studied in this trial and aren't fully known yet, similar therapies often cause flu-like symptoms such as fever and chills, fatigue, headache, nausea or vomiting.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD and/or RP2D
Number of participants with dose-limiting toxicity as assessed by labs, PE and AEs
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment1 Intervention
SNK02 will be administered as an IV infusion weekly for 8 weeks.
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Who is running the clinical trial?
NKGen Biotech, Inc.Lead Sponsor
6 Previous Clinical Trials
93 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting tests are within normal limits, or I'm on blood thinners.It has been over 2 weeks since my last palliative radiotherapy.I have not received a live vaccine in the last 30 days.I have a serious heart condition.My cancer did not respond to at least one standard treatment.I currently have COVID.I am not on immunosuppressive therapy, except for certain conditions.I am currently on a treatment that uses my body's immune system to fight cancer.I have had an organ or stem-cell transplant.It has been over 4 weeks since my last cancer treatment, not counting steroids.I have recovered from previous cancer treatments, except for moderate hair loss.I agree to use birth control as required by the study.My liver is functioning well according to recent blood tests.My cancer is spreading, cannot be surgically removed, and standard treatments are not working.I am fully active or restricted in physically strenuous activity but can do light work.My blood counts meet the required levels without needing extra help.My kidney function is good with creatinine levels at or below 2.0 mg/dL.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What can be surmised about the safety of Cohort 1?
"As a Phase 1 trial, Cohort One has limited data attesting to its safety and effectiveness. Therefore, it was granted a score of one on our scale of efficacy assessment."
Answered by AI
Is there a current opportunity to enrol in this clinical trial?
"Data hosted on clinicaltrials.gov conveys that this trial is not currently accepting candidates, as it was last amended August 10th 2023. Nevertheless, there are 2,344 other trials presently calling for volunteers to enroll."
Answered by AI
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