Information for clinicians

CAR-T cell Therapy Overview

CAR-T cell therapy is a form of cellular therapy, whereby an engineered chimeric antigen receptor (CAR) gene is introduced into T cells, allowing the T cells to identify, bind to and eradicate target cancer cells bearing the antigen of interest. CAR-T therapies have emerged as highly active therapies in a range of blood cancers including Acute Lymphoblastic Leukaemia (ALL), Lymphoma, Chronic Lymphocytic Leukaemia (CLL) and Multiple Myeloma (MM).

CAR-T therapy can be associated with considerable toxicity, which is dependent on the generation of CAR-T, the co-stimulatory molecules used, the target and the disease under treatment, and patient factors such as age, comorbidities and performance status.

The process involved in CAR-T therapy includes assessment of patient eligibility, the collection of autologous T cells through non-mobilised leukapharesis, the transport of fresh or cryopreserved cells to and from the site of manufacture, the genetic alteration of the cells using viral vectors, and the re-infusion of the CAR-T cell product with close inpatient and outpatient monitoring.

The process of CAR-T therapy can often have tight timelines associated with the patient’s disease and manufacturing slot availability. All patients must be adequately prepared physically, psychologically and socially to help them and their families cope with the procedure in the short and long term.

The Alfred CAR-T service

In April 2022, the Alfred Hospital opened its publicly funded CAR-T service offering Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel) for approved indications, with Tecartus® (brexucabtagene autoleucel) anticipated to follow later his year.

The Therapeutic Goods Administration (TGA) approved CAR-T therapies include Novartis’ Kymriah® (tisagenlecleucel) and Gilead’s Yescarta® (axicabtagene ciloleucel) for adult patients (no upper age) with Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal B cell Lymphoma (PMBCL), Grade 3B Follicular Lymphoma (FL), Richter Transformation or transformed Follicular, Marginal Zone or Lymphoplasmacytic Lymphoma, whose disease is refractory or has relapsed after at least 2 prior lines of therapy (see eligibility criteria for further details).

Kymriah® is also approved for use in B cell Acute-Lymphoblastic Leukaemia (B-ALL) in children and young adults up to 25 years of age, whose disease is refractory or in second or later relapse.

Gilead’s Tecartus® (brexucabtagene autoleucel) has been approved for use in adults with relapsed or refractory B cell Acute Lymphoblastic Leukaemia or Mantle Cell Lymphoma.

In addition, The Alfred offers an ever-expanding portfolio of clinical CAR-T cell trials for non-government funded indications in leukaemia, lymphoma, and myeloma.