CAR T-Cell Therapy

Cancer is one of the biggest medical challenges today. The incidence of cancer is increasing around the world ¹ for a variety of reasons, yet the latest statistics from the National Cancer Institute show the U.S. cancer death rate ² has steadily decreased over the last 20 years.

• For men: Average decrease of 1.8% a year
• For women: Average decrease of 1.4% a year
• For children: Average decrease of 1.4% a year

The increase in incidence and decrease in deaths is proof we’re making significant strides in treating the various forms of cancer. One of the most exciting advances in cancer treatment is chimeric antigen receptor (CAR) T-cell therapy.

Here at YourDNA.com, we have done the research into this innovative treatment plan. In this guide, you'll find valuable information in easy-to-understand terms.

What Is CAR T-Cell Therapy?

CAR T-cell therapy is a type of genetically-modified autologous T-cell immunotherapy ³, which means a person’s own immune system is used to combat the cancer.

Immunotherapy has been rapidly developing in recent years because it shows such strong promise for treating certain types of cancer in some patients.

T-cells are white blood cells produced by the thymus gland that seek out and destroy infected cells that make a person sick. With CAR T-cell therapy they are harnessed with special receptors to fight cancer from within.

It is essentially reprogramming the T-cells to make them more effective at identifying certain types of cancer cells.

This is a relatively new type of cancer treatment. CAR T-cell therapy FDA approval was first obtained in 2017.

It was a momentous occasion because it was the first time a gene therapy was approved in the U.S. It signaled a new chapter in cancer and disease treatment.

Before approval, there had been years of CAR T-cell therapy clinical trials to prove both efficacy and safety.

How Does CAR T-Cell Therapy Work?

T-cells are a core component of the immune system and serve as the basis for CAR T-cell therapy.

Although it's considered a more natural treatment method compared to chemotherapy and radiation, medical intervention is still needed because CAR T-cells don’t exist naturally.

How to Make CAR T-Cells

CAR T-cells are made by adding chimeric antigen receptors to T-cells. The receptors help the T-cells seek out and destroy cancerous cells that contain a certain molecule.

Each dose is unique because they are made using the patient’s own T-cells. The T-cells are extracted from the patient’s blood at the hospital and then sent to a lab where they are genetically modified by adding the chimeric antigen receptors to the surface of the T-cells.

The new CAR T-cells are infused back into the patient via IV where they multiply. Once the receptors are added to the T-cells they will search for cancer cells with a specific antigen and kill them.

There are a few CAR T-cell therapy companies that currently specialize in genetically modifying T-cells. Kymriah, the first CAR T-cell therapy to receive FDA approval, is made by Novartis.

How Long Do CAR T-Cells Live?

CAR T-cell therapy is what’s known as a living drug. Once the CAR T-cells are created they can live long-term in the body.

What Types of Cancer Can be Treated by CAR T-Cell Therapy?

As of this writing, CAR T-cell therapy is used to treat cancers that affect the bone marrow and blood. CAR T-cell therapy leukemia treatments have been used for a few years now.

The first type of CAR T-cell therapy to receive FDA approval ⁴ was Kymriah (tisagenlecleucel). The therapy is used to treat B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults.

It is the most common type of cancer in children. Typically, CAR T-cell therapy is used when other forms of treatment have proven to be ineffective or the cancer returns after going into remission using other treatments.

CAR T-cell therapy was also FDA approved to treat non-responsive adult B-cell non-Hodgkin’s lymphoma in 2018. CAR T-cell therapy clinical trials are underway that could lead to approval for first line and second line of treatment.

Although CAR T-cell therapy is only used to treat two forms of cancer currently, medical professionals are working hard to get approval for more. The next phase of clinical trials will likely include treatments for multiple myeloma, mantle cell lymphoma, acute myeloid leukemia and B-cell lymphoma.

CAR T-cell therapy multiple myeloma treatment could be a major breakthrough, particularly for women. Female patients with multiple myeloma have seen no change in mortality rates since 2011 while there has been a slight 0.9% decrease among men.

Right now focus is on blood cancers rather than solid cancers involving tumors. CAR T-cell therapy for solid tumors will likely begin with lymphomas that are created by lymphoma cells.

What Are Some Advantages of CAR T-Cell Therapy?

With CAR T-cell therapy the patient’s own body is used to fight cancer. Because of this, there tends to be fewer adverse reactions compared to using therapies with foreign substances.

Another huge advantage of CAR T-cell therapy is that the benefits could potentially last for years since the modified T-cells remain in the body. If there’s a relapse or resurgence of the cancer, the CAR T-cells are there to intervene.

Early CAR T-cell therapy statistics are very promising. Researchers at MD Anderson found that 66% of children with acute lymphoblastic leukemia remained in remission six months after CAR T-cell treatment.

They also found 42% of adult patients with lymphoma were still in remission ⁵ 15 months after treatment. This is significant since these patients are usually given six months to live without CAR T-cell therapy.

Last but not least, CAR T-cell therapy involves a single infusion. Patients don’t have to go through repeated treatments that can wear on their body and significantly impact their daily life.

The therapy involves two weeks of in-patient care and that’s it.

What Are the Possible Side Effects of CAR T-Cell Therapy?

As with all cancer treatments, there are known side effects associated with CAR T-cell therapy. T-cells are amazing at initiating an immune response, but that’s also one of the CAR T-cell challenges.

Cytokine release syndrome (CRS) is the most common side effect with approximately 70-90% of patients experiencing it. CRS occurs because the immune system goes into overdrive.

It causes flu-like symptoms that last 5-7 days on average.

The CRS side effects usually occur within a few days of the CAR T-cell infusion. Fortunately, there is a highly effective treatment for CRS called tocilizumab.

Another, less common CAR T-cell therapy side effect is CAR T-cell-related encephalopathy syndrome (CRES). Patients affected by CRES will become disoriented and confused, sometimes to the point of not being able to speak.

CRES usually lasts just 2-4 days and begins about five days after the infusion.

What Type of Patient Is a Good Candidate for CAR T-Cell Therapy?

Patients must have one of the two cancers that CAR T-cell therapy has been approved to treat.

The patient would already have had two other types of treatment, such as chemotherapy, that proved to be unsuccessful.

How Easy Is It for Patients to Get CAR T-Cell Therapy?

Today it’s a lot easier for appropriate patients to get CAR T-cell therapy as a third line therapy for B-cell precursor acute lymphoblastic leukemia and adult B-cell non-Hodgkin’s lymphoma.

If a patient wants to use CAR T-cell therapy as a first line or second line treatment it’s not readily available. The same goes for treating blood cancers outside of the two approved diseases.

To use CAR T-cell therapy outside of the FDA-approved methods patients have to be enrolled in a clinical trial. Getting in a clinical trial can be challenging.

Clinical trials have very specific criteria for participants, and it can take months or years for the trial to commence.

Where Is CAR T-Cell Therapy Available?

Right now a limited number of cancer centers perform CAR T-cell therapy.

It’s a new, high personalized therapy that requires a special understanding of cellular genetic modification, which means there are few practitioners that can perform CAR T-cell therapy. Facilities that offer CAR T-cell therapy include:

• Dana-Farber Boston Children's Cancer and Blood Disorder Center
• Dana-Farber/Brigham and Women’s Cancer Center
• MD Anderson Cancer Center
• Mayo Clinic
• City of Hope Comprehensive Cancer Center
• Cleveland Clinic

As mentioned above, CAR T-cell therapy is also available through clinical trials that are conducted at cancer centers and university medical centers.

What Is the CAR T-Cell Therapy Process Like for Patients?

If a patient could write a CAR T-cell therapy review, what would they say? Each patient experience is unique, but compared to other types of cancer treatment, the CAR T-cell therapy process is fairly easy.

Step 1 - Evaluation

Before CAR T-cell therapy is approved as a course of treatment, the patient must be evaluated to make sure they are a good candidate.

Step 2 - Collection

Patients that are approved will have their blood drawn. T-cells are collected from the blood and the blood is then transfused back into the patient’s body.

Step 3 - Cell Modification and Multiplication

During this step, the patient doesn’t have to do much beyond waiting. The T-cells are sent to a laboratory to be genetically engineered.

The modified T-cells are multiplied millions of times over, which takes about two weeks. The millions of CAR T-cells are frozen and sent to the cancer center where the patient is receiving treatments.

Step 4 - Pre-treatment Therapy

While the cell modification and multiplication are taking place the patient may have pre-treatment chemotherapy.

Step 5 - Infusion

CAR T-cell therapy involves a single infusion through an IV. The patient will have to be admitted to the hospital so that they can be carefully monitored after the infusion.

Step 6 - Recovery

Because only one infusion is involved, the recovery process begins immediately.

What Does the Recovery Process Entail?

The initial recovery process after CAR T-cell therapy occurs in the hospital. Patients usually stay for 2-3 weeks for observation.

Doctors want to make sure patients respond well and treat side effects as soon as they occur.

The overall recovery period is 2-3 months. During the recovery period, patients will regularly check in with their cancer team to gauge treatment response.

If complications do occur the patient may need to be admitted to the hospital again. It’s recommended that patients stay close to the treatment center for at least the first month.

What Is the CAR T-Cell Therapy Success Rate?

Success is gauged by the CAR T-cell therapy survival rate, which vary depending on the illness being treated.

Early research suggests the CAR T-cell therapy success rate for lymphoma ⁶ is impressive. More than 80% of patients participating in a clinical trial for the CAR T-cell therapy YESCARTA had complete or partial remission.

Another clinical trial for the CAR T-cell therapy KYMRIAH also had an 80% success rate among children and young adults.

The hope is that in the near future CAR T-cell therapy is so successful it replaces stem cell transplants and chemotherapy. In order for that to happen, clinical trials that are currently in progress must show that CAR T-cell therapy is just as effective at eradicating cancer before other treatments are used.

What Happens if CAR T-Cell Therapy Fails?

After CAR T-cell therapy death is delayed for many patients. But as the CAR T-cell therapy statistics above show, the treatment isn’t successful for everyone.

CAR T-cell therapy failure is always possible even for someone who is the perfect candidate.

Right now, CAR T-cell therapy is the last line of defense against aggressive cancer that isn’t responding to other treatments. That means if CAR T-cell therapy fails, patients no longer have any treatment options.

However, they may still be able to take part in clinical trials that are testing new therapies.

How Much Does CAR T-Cell Therapy Cost?

Research published in JAMA Oncology found that the cost of CAR T-cell therapy for patients is between $30,000 and $36,000.

However, if a patient gets CRS the cost increases to $56,000.

Will My Insurance Cover CAR T-Cell Therapy?

Whether CAR T-cell therapy is covered by health insurance depends on the individual’s plan. Because it is so new, many health insurance plans don’t specify if coverage is provided.

In most cases, if it is covered the patient must be clinically-eligible.

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