FAQ
Have Questions About the Process? We’ve Got You Covered
Who Qualifies for CAR T-Cell Immunotherapy?
- Patients Age:18-70
- Patient must not be pregnant and should take contraceptive measures during the treatment and for 3 months after the treatment
- BCMA positive as confirmed by Flow Cytometry or IHC No Autoimmune diseases patients
- No Immunodeficiencies, patients with HIV infection No Patients with severe infectious disease
- No Patients undertaking or undertook organ transplants within 3 months No Patients with active hepatitis B or C
- No Patients under systematical administration of glucocorticoids within 4 week before treatment
- No Severe allergic symptoms
- No Patients with psychological disorders
What Are the Possible Side Effects of CAR T-Cell Immunotherapy?
- Cytopenia – Cytopenia occurs when one or more of the blood cell types are lower than it should be. Blood consists of red blood cells which carry oxygen and nutrients around the body, and white blood cells which fight infection.
- B-Cell Aplasia – B-Cell aplasia occurs when anti-CD19 CAR T-Cells kill normal B lymphocytes that express CD19. These patients are typically at high risk of developing infections, because of their hypogammaglobulinemia. However, this can be treated with intravenous immunoglobulin (IVIG) replacement therapy.
- Cytokine Release Syndrome (CRS) – Potentially life-threatening condition that results from the pathologic over-activation of T-Cells. It is an acute systemic inflammatory syndrome characterised by fever and multiple organ dysfunction.
- Neurotoxicity – Damage to the brain or peripheral nervous system caused by exposure to natural or man-made toxic substances. These toxins can alter the activity of the nervous system in ways that can disrupt or kill nerves.
- Similar to flu-like symptoms
- Headache
- Fever
- Chills
- Muscle or joint pain
What Is the Treatment Period Like for CAR T-Cell Immunotherapy?
- The pre-evaluation phase takes up to 4 weeks. Once completed, blood collection will take 1 day. The process of manufacturing the CAR T-Cells will then take up to 4 weeks, after which you will have to undergo pre-conditioning chemo, which can last up to 4 days (2 to 14 days before CAR T-Cell infusion. After you’re done with that, the infusion of the CAR T-Cell will take 1 day, and your follow up will be between 3 to 6 months later.
What Does Compassionate Drug Mean and Why Is CAR T-Cell Under This Category?
Compassionate drug use means making a new drug, which is still in clinical trials, available to treat a seriously ill patient when no other treatments are available. This is different from the use of drugs as part of a clinical trial, which is called Investigational Use. Such drugs are only available to patients who are taking part in a clinical trial. Being able to use one of these drugs when the patient is not part of a clinical trial is commonly referred to as compassionate drug use.
Doctors and patients wishing to use CAR T-Cell Immunotherapies for solid tumours can do so under a special process called Compassionate Drug Use.
Is CAR T-Cell Immunotherapy Better Than Chemotherapy?
Chemotherapy, surgery and radiotherapy are USFDA-approved treatments that have long been used as primary and secondary treatments for cancer.
However, when cancer recurs in the future, or when these primary and secondary treatments are unable to reduce or kill cancer, then doctors and patients may opt for other types of treatments including immunotherapy and also drugs that are still undergoing clinical trials nearing FDA approval. The clinical outcomes of CAR T-Cell Immunotherapy have been impressive and have shown remarkable results in relapsed/refractory cancer patients.
However, when cancer recurs in the future, or when these primary and secondary treatments are unable to reduce or kill cancer, then doctors and patients may opt for other types of treatments including immunotherapy and also drugs that are still undergoing clinical trials nearing FDA approval. The clinical outcomes of CAR T-Cell Immunotherapy have been impressive and have shown remarkable results in relapsed/refractory cancer patients.