Chimeric antigen receptor T cell (CAR T-cell) therapy is a form of immunotherapy that is currently being investigated in clinical trials for the treatment of myeloma. Immunotherapy works by using your immune system to fight cancer. In CAR-T-cell treatment, a type of immune cell, known as T cells, are genetically programmed with a chimeric antigen receptor (CAR) protein that enables them to recognise and destroy cancerous myeloma cells in your body.
In clinical trials, researchers use specific inclusion and exclusion criteria during the enrolment process to determine the most appropriate and safe patient population to test new drugs. Your doctor will assess whether you meet these criteria and you must go through an initial comprehensive physical examination. Furthermore, regular and thorough check-ups will be carried out throughout the entire treatment process to monitor your health status. As CAR-T-cell treatment can take around six weeks to manufacture some patients may lose eligibility for enrolment in the clinical trial during this time. For example, during the manufacturing process patients may become weaker or their myeloma may progress and it is no longer safe for them to receive treatment with CAR-T-cells. Therefore, it is important to note that even if you are considered eligible and start the first phase of treatment in a CAR-T clinical trial, there is still a chance you can lose eligibility and may not receive the actual CAR-T-cell infusion.
Some common requirements for inclusion in a CAR T-cell clinical trial:
- You must be able to sign an informed consent form (in your native language) and agree to undergo all the required test procedures (such as blood tests, bone marrow biopsies, imaging, etc).
- As CAR-T-cell treatments are mostly being tested in patients who are relapsed/refractory (meaning disease that is worsening or no longer responds to treatment), you must have a documented diagnosis of myeloma with measurable disease (through blood or urine tests, imaging, or biopsy).
- Usually, an Eastern Cooperative Oncology Group (ECOG) score of fewer than 2 points is required. This score measures your overall fitness level by assessing how independently (or not) you can complete your daily activities such as bathing, cooking, etc. Patients with a higher ECOG score are considered less fit for treatment with CAR-T-cells.
- On average, you should have received at least 3 (range 2-4) previous lines of therapy (including proteasome inhibitors and immune modulators) and your myeloma should have worsened after or during your last treatment.
- You must have good functioning organs such as your kidney, liver, and heart. Organ function will likely be measured to determine your eligibility and how safe it is for you to participate in a CAR-T-cell clinical trial.
- Your neutrophil count (a type of immune cell) and platelet counts (a type of cell your body uses to stop bleeding) may also be taken into consideration.
- Also, often your life expectancy must be estimated to be greater than 3 months.
Some common reasons why you would not be able to participate in a CAR-T-cell clinical trial:
- You have an active hepatitis B virus (HBV) infection; hepatitis C virus (HCV) infection; HIV infection; syphilis infection; or an active, uncontrolled viral, bacterial, or fungal infection.
- You have an uncontrolled heart or vascular disease (e.g., frequent heart-related chest pain, uncontrolled high blood pressure, stroke, or heart attack, etc within 6 months of screening for enrolment into the clinical trial).
- You suffer from an uncontrolled liver, kidney, or metabolic disease.
- You have an autoimmune disease that requires treatment with drugs that suppress your immune system.
- You have an uncontrolled medical or psychiatric disorder that would influence the outcome of CAR-T-cell treatment.
- You are pregnant or breastfeeding.
- You have a history of a disease related to your nervous system causing frequent seizures, brain damage, dementia, or Parkinson’s disease.
- You have another cancer or have myeloma disease outside of your bone marrow (also known as extramedullary disease), although this may vary.
Please note, this is not a comprehensive list, and criteria for inclusion or exclusion in CAR-T-cell clinical trials may vary. This list is based on research carried out by MPE, during which protocols of 15 CAR-T-cell clinical trials were reviewed on www.clinicaltrials.gov. We advise that you consult your physician for further information or advice on your eligibility for a CAR-T-cell clinical trial.
For more information about myeloma, CAR T-cells and other treatments for myeloma check out the CARAMBA CAR-T clinical trial publication and ensure you follow MPE on social media: Facebook, Twitter, YouTube and LinkedIn.