NKGen Biotech is currently conducting clinical trials to evaluate the potential benefits of our SNK therapy with the goal of improving outcomes for patients with neurodegenerative diseases and cancer.
NKGen Biotech is working to bring innovative cellular immune therapies to people with neurodegenerative diseases and cancer. We are currently conducting clinical trials with our super-activated NK cell therapy in patients with neurodegenerative disease (SNK01) and cancer (SNK02). Clinical trials ensure that a new therapy is safe and effective by administering the treatment to trial patients and healthy volunteers to generate safety and efficacy data. Clinical trials are a key component in the cell therapy regulatory approval process and are an essential step in the path towards commercialization. Learn more about clinical trials at www.clinicaltrials.gov.
Active Clinical Trials
|SNK01-US01||Advanced Solid Tumors, Adult||Sarcoma Oncology Research Center, Santa Monica, CA||Active, not recruiting||NCT03941262||Phase I, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients with Pathologically Confirmed Cancer Refractory to Conventional Therapy|
|SNK01-MX04||Alzheimer’s Disease||Hospital Angeles Tijuana, Tijuana, B.C., Mexico||Recruiting||NCT04678453||Single Center, Open Label, Phase 1 Study to Evaluate the Safety, Tolerability and Exploratory Efficacy of SNK01 in Subjects With Alzheimer’s Disease (AD)|
|SNK02-202||Refractory Solid Tumors||Sarcoma Oncology Center, Santa Monica, CA||Not yet recruiting||NCT05990920||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|
For more information, please click on the NCT# above to access the study details. You will be taken to the www.clinicaltrials.gov study specific webpage. Information on enrollment can be found by contacting the study coordinator listed in the ‘Contacts and Locations’ section. When considering enrolling in a clinical trial, please consult with your healthcare provider first to discuss the risks and the benefits and to determine whether participating in a clinical trial is right for you.
Expanded Access Program
NKGen Biotech, Inc.’s Expanded Access program allows for potential access to investigational therapies in certain rare circumstances in which a patient has no other available therapy options. Investigational therapies have not yet received regulatory approvals and the risk and benefits have not been fully established. If a patient is not eligible to participate in a current NKGen Biotech, Inc. sponsored clinical trial, there are different regulatory pathways in various countries to provide access to our investigational therapies. Our expanded access program is part of our ongoing commitment to ensure that our innovative medicines are made available to patients who have limited options.
Treating physicians may request information about expanded access for an NKGen Biotech, Inc. investigational therapy by contacting IST@nkgenbiotech.com or 949-396-6830. NKGen Biotech, Inc. will evaluate these requests individually and will acknowledge receipt of the request via telephone call or email within seven business days of receipt.
Access to Investigational Medicines
NKGen Biotech, Inc. is focused on improving patients’ lives through the development and commercialization of innovative natural killer cell therapies that address unmet medical needs. NKGen Biotech, Inc. is committed to bringing new therapies to patients by conducting rigorous clinical trials to assess the safety and efficacy of our therapies and obtaining marketing approval by the FDA and other relevant regulatory agencies.
At NKGen Biotech, Inc. we believe that whenever possible, the best way for patients to gain access to investigational medicines is through participation in clinical trials. However, in some specific situations where participation in a clinical trial is not feasible, patients with serious or life-threatening conditions or diseases may seek special access to investigational medicines outside of a clinical trial (referred to as compassionate use or expanded access). NKGen Biotech, Inc. offers single patient compassionate use through our Expanded Access Program.
Single Patient Expanded Access — Eligibility Criteria
NKGen Biotech, Inc. considers many factors when evaluating a request for individual patient access to an investigational medicine. NKGen Biotech, Inc. may consider individual compassionate use access requests only when the following criteria are met:
- The disease or condition is serious or life threatening.
- All available therapies typically used to treat the disease or condition have been exhausted.
- No other treatment options are available including participation in a clinical trial.
- There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks.
- NKGen Biotech, Inc.’s clinical development program will not be compromised by providing compassionate access.
- Adequate supply of the investigational therapy exists to support both ongoing clinical trials and approved compassionate use requests.
- The request for compassionate use access must be made by the patient’s treating physician.
- NKGen Biotech, Inc. may request additional information about the patient to enable a complete evaluation, including but not limited to patient history.
NKGen Biotech, Inc. will evaluate the individual patient access request based on the above criteria; however, NKGen Biotech, Inc. cannot guarantee that access to a particular patient will be granted or that the investigational therapy will be available to a particular patient.
All requests for individual compassionate use access are considered on a case-by-case basis in a fair and equitable manner. NKGen Biotech, Inc. bases all decisions on clinical circumstances to ensure an impartial evaluation.
For additional information:
Treating physicians in the U.S. can contact NKGen Biotech, Inc. via email to IST@nkgenbiotech.com to request the documents that need to be completed for evaluation.
For more information about NKGen Biotech, Inc.’s clinical trials, please see Active Clinical Trials section above or search for NKGen Biotech on www.clinicaltrials.gov.