- Patient is well enough to receive CAR T-Cell Immunotherapy.
- Tumour has expressed the appropriate marker, e.g. CD19.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Absence of disease complications or chemo-toxicity; such as, infection, active GVHD, hyperleucocytosis, severe extra medullary disease.
- Last dose of chemotherapy and/or steroid is at least 2 weeks prior; when in doubt, a T-Cell activation test will be performed.
- Patient’s tumour burden is as low as possible. In patients with uncontrolled or accelerating tumour burden, induction chemotherapy should be performed first (apheresis should be done prior to commencing the chemotherapy).
- 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.
- T-Cell Cryopreservation Option
- Pre-assessment – Up to 4 weeks.
- Pre-treatment phase (apheris, CAR T-Cell manufacturing, conditioning chemotherapy) – Up to 6 weeks.
- Treatment (CAR T-Cell infusion, monitoring) – Up to 1 week.
- Post-treatment Monitoring (follow up) – Up to 24 weeks.