CAR-T Therapy Patient Roadmap

Most people who receive CAR-T therapy have already been through other cancer treatments. It's typically recommended when the cancer has come back after treatment or hasn't responded the way doctors had hoped. Your care team will review your treatment history and help determine whether it's the right next step for you.

CAR-T therapy isn't the right treatment for every type of cancer, but it can be a powerful option for certain blood cancers, including some types of non-Hodgkin lymphoma, lymphoid leukemias and multiple myeloma. Your doctor will review your diagnosis and talk with you about whether CAR-T is the right fit for your specific situation.

Before moving forward, we'll make sure your body is ready for treatment. That includes checking how well your heart, lungs and kidneys are working, reviewing your overall health and making sure you don't have any serious active infections. These evaluations help us provide CAR-T therapy as safely as possible.

One of the most important parts of CAR-T therapy is having someone by your side. You'll need a dedicated caregiver who can stay with you around the clock for about 30 days after treatment. They'll help drive you to appointments, keep an eye on your temperature and other vital signs, watch for any changes in how you're feeling or thinking and help you stay on track with your medications.

Your first visit is a chance for us to get to know you and for you to get to know us. We'll review your medical history, talk through the CAR-T process step by step and answer any questions you have along the way. We'll also discuss the potential benefits and risks of treatment so you can make an informed decision with confidence.

CAR-T therapy is a team effort, and you'll have experts supporting you every step of the way. During your evaluation, you'll meet your Cellular Therapy Physician and an Advanced Practice Provider (APP), along with several other members of your care team.

You'll also be introduced to your Nurse Coordinator, who will be your main point of contact throughout treatment, as well as a Social Worker and Financial Navigator who can help with practical questions, resources and support along the way.

Before treatment begins, we'll complete a series of tests to make sure your body is ready for CAR-T therapy and to help us create the best treatment plan for you. Depending on your individual needs, these may include:

• Blood tests
• Imaging, such as a PET/CT scan, to better understand your cancer
• A brain MRI to establish a baseline, if needed
• An echocardiogram to evaluate your heart
• Pulmonary function tests to check your lung function
• A bone marrow biopsy, if recommended by your care team

From the day your cells are collected to the day they're infused back into your body, the process typically takes about three to six weeks. Since every treatment is made specifically for you, the exact timeline depends on how long it takes to prepare your personalized CAR-T cells. Your care team will keep you informed every step of the way and let you know what to expect throughout the process.

The first step is collecting your T-cells. During this outpatient procedure, you'll relax in a comfortable chair while your blood is drawn through an IV or central line. A specialized machine separates and collects your T-cells before returning the rest of your blood to your body. The appointment usually lasts four to six hours, so feel free to bring a book, watch TV or simply rest while the collection takes place.

After your T-cells are collected, they're sent to a specialized laboratory where they're carefully modified to recognize and attack your cancer cells. This process usually takes three to six weeks.

While your personalized cells are being prepared, your doctor may recommend a temporary treatment, called bridging therapy, to help keep your cancer under control until your CAR-T cells are ready.

A few days before your infusion, you'll receive a short course of chemotherapy called lymphodepletion. Unlike traditional chemotherapy, this treatment isn't meant to destroy your cancer. Instead, it prepares your immune system by creating space for your new CAR-T cells to grow, multiply and begin working once they're infused. This part of treatment typically takes three days.

When your personalized CAR-T cells arrive back, they'll be thawed and infused into your bloodstream through an IV. The infusion itself is similar to receiving a blood transfusion and usually takes 15 to 30 minutes.

Although the infusion is relatively quick, you'll spend additional time with us afterward so we can monitor you closely and make sure you're feeling well before you leave.

The infusion usually takes 15 to 30 minutes, but plan to spend most of the day at the Cancer Institute so we can monitor you afterward. This extra observation time allows us to make sure you're feeling well before you leave. Your caregiver and family members are welcome and encouraged to stay with you throughout your appointment.

Infusion day is often much simpler than people expect. When you arrive, our team will check your vital signs and give you medications, such as Tylenol® and Benadryl®, to help reduce the risk of an allergic reaction. Once everything is ready, your personalized CAR-T cells will be infused through an IV.

CAR-T therapy works by activating your immune system to fight cancer. As those cells begin doing their job, some people experience side effects that require close monitoring. Two of the most common are:

• Cytokine Release Syndrome (CRS) can feel like a severe case of the flu and may cause fever, chills, low blood pressure or low oxygen levels.
• Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) affects the nervous system and may cause temporary confusion, difficulty speaking, tremors or severe headaches.

Most side effects are manageable when they're recognized early, which is why your care team will monitor you closely and teach both you and your caregiver what to look for once you're home.

If you develop a fever of 100.4°F or higher, have trouble breathing, feel dizzy or lightheaded, or if your caregiver notices you're confused or having trouble speaking, contact us right away. These symptoms can be a medical emergency and should never be ignored.

Call our 24/7 CAR-T Hotline immediately. Your care team will provide you with that phone number. If your care team advises you to come in, or if your symptoms are severe, go directly to Emergency Department. Please do not go to an urgent care clinic or another hospital, as our specialized team is best equipped to care for patients receiving CAR-T therapy.

Recovery looks a little different for everyone, but many patients begin feeling much better and are able to return to light daily activities within two to three months.

One important exception is driving. Because CAR-T therapy can occasionally cause delayed neurological side effects, the FDA requires that patients do not drive or operate heavy machinery for eight weeks after their infusion. Your care team will let you know when it's safe to resume your normal activities.

After your infusion, we'll stay in close contact to make sure you're recovering safely. For the first 14 days, you'll return to the Cancer Institute every day so we can monitor your progress, check for side effects and answer any questions you may have. As you continue to recover, those visits will become less frequent.

Throughout your recovery, we'll use a combination of blood tests, imaging and other evaluations to see how your body is responding. Around Day 30 and again around Day 100, your care team will typically perform blood work, a PET scan and, in some cases, a bone marrow biopsy to evaluate your response to treatment. We'll review your results together, explain what they mean and discuss the next steps in your care.

Even after your recovery is complete, we'll continue checking in with you over the years ahead. Because CAR-T therapy uses genetically modified versions of your own immune cells, the FDA requires long-term follow-up for 15 years.

During these annual visits, we'll monitor your blood counts, immune system function and overall health, while also screening for any rare long-term effects. Our goal is to continue supporting you long after your treatment is complete.