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CAR-T cell therapy treatment overview

Mayo Clinic's CAR-T Cell Therapy Program is one of a very few such programs at select medical centers with experts trained and certified to manage this promising area of cancer treatment.

Click here to learn more about the steps of CAR-T cell therapy treatment

Evaluation

To be considered for the Mayo Clinic CAR-T Cell Therapy Program, most patients must have already received standard of care chemotherapies.

The CAR-T cell therapy process starts with an evaluation from a Mayo Clinic doctor who specializes in the type of cancer or medical condition you have. This appointment is often called the initial evaluation. Your specialist will review your medical records and talk with you about your disease, diagnosis, past treatments, and treatment options available at Mayo Clinic specifically tailored to your condition and needs. He or she may have you undergo additional tests.

Bring with you all of your medical information, including:

  • Medical records
  • Tissue and slides from your most recent biopsy
  • Images from your most recent radiology scans

Having this information with you can help prevent delays or repeat scans or procedures. For this initial evaluation, plan on staying near Mayo Clinic for up to five business days in order to complete needed tests.

After completing scheduled tests and appointments, you will talk with a member of your team about available treatment options that meet your unique situation. CAR-T cell therapy may not be an option for everyone. If CAR-T cell therapy is an option for you, your team discusses additional evaluation steps where you will meet with a CAR-T cell specialist and many other specialists who can help assess your health.

To proceed with further evaluation for CAR-T cell therapy eligibility, you and your doctor will develop a plan that includes additional required testing and the timing of the infusion. Whenever possible, evaluations will be completed within one week.

The wait time for a CAR-T cell therapy appointment depends on several factors, including your condition, laboratory capacity and the demand for services. Mayo Clinic is committed to ensuring all people offered an appointment receive timely and excellent care and works to reduce the wait time as much as possible. Most people return home while waiting for an appointment to become available.

Insurance coverage and prior authorization

Most health insurance companies require a prior authorization for CAR-T cell therapy. Mayo Clinic's business office will work with your insurance company to get written approval and identify the plan of coverage. Additional treatment steps cannot begin until Mayo Clinic receives approval from your insurance company.

What to expect during your CAR-T cell therapy

Collection

You will undergo the process of white blood cell collection known as leukapheresis. During collection, you will be connected to a machine that separates your white blood cells from the rest of your blood. The collection process takes about five hours.

This may be done during the same visit as your CAR-T cell consultation, depending on the timing of the completion of insurance authorization and testing. Or you may need to return to the clinic at a later time for this collection.

Processing

Once enough white blood cells are collected, the cells are shipped to a special laboratory for processing where the T cells are genetically modified to activate their ability to kill your cancer. This process can take, on average, a few weeks. Most people return home during this phase.

Your care team will talk with you about how long you can expect processing to take and how to track the progress of your cells. You will need to follow the management plan outlined by your care team and report any new or worsening symptoms to your CAR-T care team using the instructions provided.

Chemotherapy before infusion

When your cells are ready, you will return to Mayo Clinic for treatment. Testing and appointments are needed to make sure you are ready to have the CAR-T cells infused into your body. It is important to understand that, even at this point, testing may show that CAR-T cell therapy is no longer a treatment option.

In preparation for your CAR-T cell infusion, you will undergo chemotherapy. Most people start chemotherapy about five days before CAR-T cell infusion. At this time, day-to-day care likely changes to a hospital-based care team. Your care team monitors your health and progress each day. You may have daily lab tests.

From this point on, plan on being at Mayo Clinic for many weeks, depending on your medical needs. During this time, you will need to stay within 30 minutes of Mayo Clinic and will not be able to drive for many weeks following infusion. Talk with your care team about driving restrictions after CAR-T cell infusion.

Infusion

After chemotherapy, the CAR-T cell infusion can take place. The day the CAR-T cells are put into your body is also called day zero. The infusion of CAR-T cells typically takes 30 to 90 minutes. However, plan for the infusion visit to take up to six hours to allow for care before and after the infusion.

Once your infusion is complete, your CAR-T doctor will tell you if you need to stay in the hospital for monitoring. Caregivers should remain with you 24 hours a day when you are not in the hospital.

Care after infusion

You will be monitored closely for many weeks after the CAR-T cell infusion. Frequent monitoring can help identify potentially life-threating reactions to CAR-T cell therapy early. Monitoring may include physical exams, blood tests and assessing your ability to do simple tasks. You may have one or more physical exams each day at the beginning. You may be asked to do simple, self-monitoring tasks several times a day.

Most people have a reaction to CAR-T cells that requires them to stay in the hospital for days to weeks for monitoring and treatment. Typically, the reaction happens within hours to days after the infusion. Not all people have a reaction.

Returning home

You will meet with your CAR-T cell specialist to understand the effect of the therapy and develop a plan for the future and for returning home. Once your health is stable, your care will transfer back to your local care provider.

In general, you will need to return to Mayo Clinic frequently for appointments during the first year after CAR-T cell therapy, and ongoing care may be needed for months to years after CAR-T cell therapy.

An opportunity to be part of research

If you are eligible to undergo treatment at the Mayo Clinic CAR-T Cell Therapy Program, your doctor may invite you to be part of one of multiple clinical trials testing CAR-T cell therapy in your condition.

Mayo Clinic is also testing this treatment in other types of cancer and medical conditions. Talk with your doctor about whether you may be eligible.

Appointments

Be sure to mention that you are interested in learning if CAR-T cell therapy will be an option for your care. Please call to check if we have CAR-T cell therapy for your cancer type and to request an appointment for a consultation.

  • Rochester: 507-284-8707
  • Arizona: 480-342-4800
  • Florida: 904-956-3309

Costs and insurance

CAR-T cell therapy is a newer type of cancer treatment that may be more expensive than other therapies. Not all insurance policies cover CAR-T cell therapy. The out-of-pocket cost for CAR-T cell therapy will vary depending on the level of coverage your insurance offers for both services at Mayo Clinic and CAR-T cell therapy itself.

When considering your treatment options, work with your health insurance provider to understand what costs are covered by your insurance and which costs you'll be expected to pay. When you are seeking to understand insurance coverage for CAR-T cell therapy at Mayo Clinic, we suggest you call your insurance company and ask the following questions:

  • Does my insurance plan include coverage at the Mayo Clinic location I am seeking treatment at?
  • Does my insurance plan provide coverage for CAR-T cell therapy? If not, is there a review process?

Your treatment can't begin until Mayo Clinic confirms with your insurance company that you're covered and preauthorized for CAR-T cell therapy.

Oct. 15, 2019
  1. Locke FL, et al. Clinical and biologic covariates of outcomes in zuma-1: A pivotal trial of axicabtagene ciloleucel (AXI-CEL; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL). Presentation. 2017 annual meeting of European Hematology Association, June 24, 2017, Madrid, Spain. https://learningcenter.ehaweb.org/eha/2017/22nd/181753/yi.lin.clinical.and.biologic.covariates.of.outcomes.in.zuma-1.a.pivotal.trial.html?f=m3. Accessed Oct. 27, 2017.
  2. Neelapu SS, et al. Chimeric antigen receptor T-cell therapy: Assessment and management of toxicities. Nature Reviews Clinical Oncology. 2018;15:47.