Clinical Trials
About our clinical trials.
What is a clinical trial and who oversees them?
A clinical trial is a research study intended to determine if a potential new way to prevent, detect, or treat disease is safe and effective in people with a particular disease or condition. Clinical trials involving volunteer participants are the primary way that researchers evaluate whether a new drug or treatment will work and/or whether it may be more effective, or have fewer side effects, than existing drugs or treatments. According to the U.S. National Institutes of Health (NIH), clinical trials are at the heart of all medical advances and help medical providers and researchers learn more about disease and improve health care for people in the future.
Clinical trials in most countries are strictly regulated by government agencies. In the U.S., clinical trials are regulated by the Food and Drug Administration (FDA), part of the federal Department of Health and Human Services. Before the FDA approves a clinical trial involving human volunteers, scientists must first perform laboratory tests and studies in animals to evaluate whether a treatment is safe and potentially effective. If these early phase trials show favorable results, the FDA can then approve human clinical trials.
Independent Review Boards (IRBs), which comprise experts in a given therapeutic area, monitor clinical trials to make sure appropriate steps are taken to protect the rights and welfare of trial participants. Under FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research. Visit the FDA website for more information on how IRBs work.
What are Natural Killer Cells (NK cells) and how does ANKTIVA® enhance therapeutic response?
The immune system is a collection of diverse cells, each with a distinct role in protecting us from infections and diseases. Among these are the natural killer (NK) cells, the body’s first line of defense. As part of the ‘innate’ immune response, NK cells have the ability to recognize and destroy abnormal (such as cancerous or virally-infected) cells and are uniquely powerful. They are always activated and ready to eliminate diseased cells without delay. We harness this power with our activated natural killer (aNK) platform based upon NK cells from a distinct cell line.
To further leverage the power of innate immune responses, we have developed a proprietary IL-15 superagonist, Anktiva® (N-803), which selectively activates NK cells and T effector cells, without activating regulatory T cells that may dampen responses. These platforms can be combined for clinical synergy in patients and such combination has produced complete responses in difficult-to-treat cancers, such as Merkel Cell Carcinoma (MCC), advanced pancreatic cancer, and advanced triple negative breast cancer (TNBC).
Why are clinical trials important for cancer patients?
Cancer claims millions of lives around the world every year. Cancer researchers are working constantly to identify new treatments for cancer patients that will be better, more effective and/or safer than treatments that exist today. Clinical trials are a vital step in developing those treatments so they can be prescribed to patients and move us ever closer to a cure. Cancer patients who volunteer to participate in a clinical trial are not only advancing research, but also helping ensure new and better treatments are available for other cancer patients.
How can I participate in a clinical trial?
Most clinical trials in the United States (and globally) are listed in a database maintained by the National Library of Medicine, and available at the clinicaltrials.gov website. Individuals can search that site by disease or condition, or in other ways, to locate clinical trials of potential interest to them and learn how they or their doctors can contact the researchers in charge of the study. If you are interested in participating in one of ImmunityBio’s clinical trials, it is easy to apply: Simply complete the patient form on our website and a member of our team or a trial partner will follow up with you.
Am I prepared for additional costs that may be incurred?
Although treatment costs are covered, there may also be other costs considered to be standard-of-care therapy, which will be the responsibility of you and/or your insurance company.
Key Questions to Ask Yourself:
Can a trial give me access to treatments I can’t get otherwise?
Am I prepared for possible side effects or if the new treatment doesn’t work?
Do I have the time, energy, and ability to meet trial requirements (i.e., visits and tests)?
Where to learn more:
- Ask your doctor about open clinical trials
- Check with local hospitals or academic centers
- Explore resources from the FDA and CISCRP
- Reach out to advocacy groups for support
Clinical Trials – Phases
Learn about the four clinical trial phases
Phase 1
- Typically lasts 6 months to 1 year
Main Goals:
- Check if the investigational medication is safe
- Identify any side effects
- Understand how the medication is processed and eliminated by the body
- Determine the right dosage and how often it should be taken
Participants:
- Involving 20 to 100 volunteers
- Usually healthy individuals, but not always
Location:
- Trials are conducted in a clinic or hospital setting
Phase 2
- Typically lasts 6 months to 1 year
Main Goals:
- How well the investigational medication or vaccine works
- If the investigational medication or vaccine is safe
- If there are any side effects
- How much of the investigational medication or vaccine is needed and how often
Participants:
- Involving 100 to 500 volunteers
- Usually healthy individuals, but not always
Location:
- Trials are conducted in a clinic or hospital setting
Phase 3
- Typically lasts 1 to 4 years
Main Goals:
- Confirm that the investigational medication or vaccine is effective
- If the investigational medication or vaccine is safe
- Identify and monitor side effects
- Compare the medicine or vaccine to commonly used treatments
Participants:
- Involving 1000 to 5000 volunteers
- Usually healthy individuals, but not always
Location:
- Trials are conducted in a clinic or hospital setting
Phase 4
- Typically lasts 1 to 4 years
Main Goals:
- The medicine or vaccine and its safety, side effects, and effectiveness
- Marketed products that are studied for new indications
Participants:
- Involving 1000’s of volunteers
- Usually healthy individuals, but not always
Location:
- Trials are conducted in a clinic or hospital setting
As part of our mission to deliver the latest medical breakthroughs, CSSIFM medical providers conduct clinical trials that test new treatments for a wide range of patients and cancer types. The following trials are being conducted at CSSIFM and new ones are on the horizon.
As part of our mission to deliver the latest medical breakthroughs, CSSIFM medical providers conduct clinical trials that test new treatments for a wide range of patients and cancer types. The following trials are being conducted at CSSIFM and new ones are on the horizon.
For more information, fill out the applicable clinical trial Inquiry form.
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