CAR T-Cell Therapy Top Frequently Asked Questions Answered

1. Where is CAR-T cell therapy available?

The FDA has approved CAR-T therapy in several countries, notably the USA, Canada, Germany, France, India, Spain, the UK, Italy, Israel, Australia, Singapore, and China.

2. What cancers can be treated with CAR-T-cell therapy?

Different pharmaceutical companies produce various forms of CAR T cell treatment. CAR T cell treatments authorized by the FDA address the following conditions:

• B cell acute lymphoblastic leukemia in both adults and children
• Some subtypes of B cell lymphoma, such as but not restricted to:
  High-grade B cell lymphoma
  Follicular lymphoma
  Primary mediastinal large B cell lymphoma
• Mantle cell lymphoma
• Multiple myeloma

3. What are the eligibility criteria for the CAR-T procedure?

• During the six weeks it can take to create CAR-T cells, some patients may no longer be eligible to participate in the research trial.
• It is necessary to have a confirmed diagnosis of myeloma (via blood or urine tests, imaging, or biopsy) as CAR-T-cell treatments are mostly being evaluated in individuals who are relapsed/refractory (meaning disease that is worsening or no longer respond to treatment).
• Less than a 2-point Eastern Cooperative Oncology Group (ECOG) score is typically needed. Individuals who score higher on the ECOG are deemed less suitable for CAR-T cell therapy.
• Proteasome inhibitors and immune modulators are among the minimum number of therapy lines you should have received, on average, 2-4, and your myeloma should have become worse during or after your most recent treatment.
• Your heart, liver, and kidneys must all be in good working condition.
• The number of neutrophils (a type of immune cell) and platelets (a type of cell used to stop bleeding) is also assessed.
• Furthermore, you should typically expect your life expectancy to be longer than three months.

4. Are children eligible for the CAR-T procedure?

• Under some circumstances, children can receive CAR-T (chimeric antigen receptor T-cell) therapy. Children with specific cancers, including diffuse large B-cell lymphoma (DLBCL) and relapsed or refractory acute lymphoblastic leukemia (ALL), are eligible to receive CAR-T therapy.
• However, the requirements for receiving CAR-T therapy in children may change based on several variables, including the precise kind and stage of the malignancy, prior medical history, general health, and other unique circumstances. Generally, CAR-T therapy is offered to kids who have not improved with conventional therapies or who have relapsed after starting treatment.

5. What are the tests done before and after the treatment?

Test before CAR-T treatment:

• Diagnostic testing: To determine the extent of the cancer and how it has responded to prior therapies, Diagnostic testing is done. These may include imaging tests like CT, MRI, or PET scans. To confirm the diagnosis and identify the cancer cells, biopsies may also be carried out.
• Blood Tests: A full blood count (CBC), tests to measure the levels of specific biomarkers or tumor markers, liver and kidney function tests, and other tests are performed to evaluate the patient’s general health and check organ function.
• Cardiac Evaluation: To evaluate heart function and detect any pre-existing cardiac disorders, patients may undergo cardiac assessments, such as electrocardiograms (ECGs) and echocardiograms.

Following CAR-T treatment:

• Tests for Lung Function: Lung function tests, or PFTs, can evaluate lung health and detect any underlying respiratory disorders that might affect a patient’s eligibility for treatment or safety.
• Viral Screening: To determine the risk of viral reactivation during CAR-T therapy, patients may be subjected to screening tests for infectious disorders such as HIV, hepatitis B, and hepatitis C.
• Cytokine Release Syndrome (CRS): Fever, hypotension, and systemic inflammation are the identifiers are the adverse effects of this treatment. Patients are continuously watched for CRS signs and symptoms, and blood tests to measure levels of inflammatory markers like interleukin-6 (IL-6) may be performed.
• Neurological Monitoring: Another possible adverse effect of CAR-T therapy is neurological toxicity, which can result in seizures, disorientation, or other neurological symptoms.
• Evaluation of Treatment Response: To evaluate the effectiveness of CAR-T therapy and keep an eye out for any indications of disease progression or recurrence, imaging studies, and blood tests may be carried out regularly.
• Long-Term Follow-Up: Following CAR-T therapy, patients usually receive long-term follow-ups to check for side effects, evaluate the durability of the treatment, and administer supportive care as needed.
• Immunological Monitoring: Research may be done to find out how long CAR-T cells remain in the patient’s body, how well they work, and how they affect the immune system.

6. Is CAR-T a one-time treatment?

CAR-T therapy only requires a single infusion of genetically altered T cells into the patient’s body, it is usually given as a one-time procedure. These T cells have been altered and fitted with chimeric antigen receptors (CARs), which enable them to identify and specifically target certain proteins in cancer cells, ultimately resulting in their demise.

Though the infusion is a one-time treatment, CAR-T therapy can have long-lasting effects, possibly even curing certain patients or achieving durable remission. To treat any adverse effects and keep an eye out for a recurrence of the disease, patients might also need continuous monitoring and supportive care.

7. Is a hospital stay required before, during, or after the procedure?

Hospitalization is typically necessary for a few hours before, during, and following the CAR-T infusion. This is an explanation:

Before the Process:

• Before beginning treatment, patients usually go through a pre-treatment examination that includes diagnostic tests and assessments to make sure they satisfy the requirements for CAR-T therapy eligibility.
• Leukapheresis is a procedure where patients’ blood is drawn to separate white blood cells, including T cells, in advance of the CAR-T injection.

During the treatment:

• The CAR-T infusion is usually performed as an inpatient operation. Patients are closely observed for indications of early adverse effects, such as neurotoxicity or cytokine release syndrome (CRS), following the administration of the CAR-T cells. If such issues arise, hospitalization enables timely action and supportive treatment.

Following the Procedure:

• Patients are typically monitored in the hospital for a while after receiving a CAR-T infusion to check for any possible adverse effects and make sure they are stable before release.
• Depending on several factors, including the patient’s reaction to treatment, side effects, and institutional protocols, the length of hospital stay following CAR-T therapy may differ. Within a few days, some patients might be released from the hospital, while others might need to stay longer for monitoring and supportive care.

8. What are the possible side effects of CAR-T?

These side effects can include the following:

• One of the most frequent and potentially dangerous side effects of CAR-T therapy is cytokine release syndrome (CRS). Mild to severe symptoms of CRS can include chills, fever, nausea, vomiting, exhaustion, fast heartbeat, low blood pressure, breathing difficulties, and organ malfunction.
• Aphasia (difficulty speaking or understanding speech), seizures, tremors, confusion, delirium, and reduced consciousness are examples of neurologic side effects that some CAR-T treatment patients may encounter. The conditions known as immunological effector cell-associated neurotoxicity syndrome (ICANS) may be indicated by these symptoms.
• Hypogammaglobulinemia and B-cell aplasia: CAR-T treatment can potentially reduce the number of healthy B cells in the body, lowering immunoglobulin levels and raising the risk of infection, especially in the months after treatment.

9. What is the success rate of CAR-T therapy?

According to research, CAR T-cell therapy produced a complete remission in 9 out of 10 patients with acute lymphoblastic leukemia whose disease either didn’t respond to previous treatments or relapsed. In remission, diagnostic testing is unable to identify the malignancy.

10. What are the chances of cure or remission?

For non-Hodgkin lymphoma and chronic lymphocytic leukemia, complete remission rates range from 35 to 70%. About one-third of them experience long-lasting remissions. Certain patients are cured. A sizable portion of patients will experience long-term remission. For others, though, remissions might only last for a while.

A recent research monitored patients undergoing acute lymphoblastic leukemia treatment. Following CAR T-cell therapy, almost 85% of the patients experienced total remission, and 60% of those patients continued to be cancer-free a year later. However, a review of the literature on CAR T-cell therapy found that a sizable portion of patients did not see improvement with this treatment.

11. What is the recovery period after the procedure?

After receiving an infusion, patients should anticipate a two- to three-month risk/recovery period and a possible two-week hospital stay. Patients are assessed for adverse effects and response to treatment during this period. Patients are frequently admitted to the hospital during this time to treat issues. For the first thirty days following CAR T-cell injection, patients need to stay near the hospital to receive routine follow-up treatment.

12. How much does CAR-T cell therapy cost?

The type of therapy, the healthcare provider, the patient’s location, and other considerations can all have a substantial impact on the cost of CAR-T cell therapy. It’s crucial to remember that as the therapy gains popularity and new therapies are created, the cost may fluctuate.

13. Who are the best doctors for CAR-T cell therapy?

The best doctors for CAR-T cell therapy are following:

In India

• Dr. Esha Kaul (Maz Super Speciality Hospital, Noida and Vaishali)
• Dr. Prashant Mehta (Amrita Hospital, Faridabad)

In Turkey

• Dr. Seref Komurcu (Anadolu Medical Center, Istanbul)
• Dr. Bulent Karagoz (Anadolu Medical Center, Istanbul)

In UK

• Dr. Michael Potter (Royal Marsden Hospital, London)
• Dr. Richard Kaczmarski (Hillington Hospital, London)

In UAE

• Dr. Deborah Mukherji (Clemenceau Medical Center Hospital, Dubai)
• Dr. Fadi El Karak ((Clemenceau Medical Center Hospital, Dubai)

14. What strategies can be undertaken for better outcomes of the CAR-T procedure?

A comprehensive plan that caters to the physical, emotional, and psychosocial requirements of cancer patients undergoing CAR-T therapy during their treatment journey is necessary for ensuring their optimal recovery. A supportive environment is created through support groups and counseling services, individual treatment plans that are customized to each patient’s particular needs, access to comprehensive rehabilitation programs to improve their physical health and quality of life, and empowering patients with knowledge and resources to manage side effects of treatment and advance general well-being are all important strategies. Improved recovery outcomes can also result from facilitating smooth coordination and communication among medical professionals and including patients in joint decision-making.