CAR T-cell Therapy

CAR T-cell therapy is a new form of immunotherapy that uses specially altered T-cells to directly and precisely target cancer cells.

The immune system is made up of a variety of cells and organs that normally protect the body from infection and cancer.

An important component of the immune system are T-cells, which have the capacity to hunt down and destroy abnormal cells, including some cancer cells.

Sometimes, cancer cells find ways to evade the immune system so the immune system needs to be retrained and enhanced to recognize and attack cancer cells.

CAR T-cell therapy is one innovative approach to program and strengthen the immune system to attack some forms of cancer.

After a small portion of a patient's own T-cells have been collected from the blood, they are re-engineered in a special laboratory to carry special structures called chimeric antigen receptors (CARs) on their surface.

When these CAR T-cells are reinjected into the patient, they multiply rapidly. These engineered receptors may help the T-cells to identify and attack cancer cells throughout the body.

In Australia, CAR T-cell therapy has been approved in B-cell acute lymphoblastic leukaemia (ALL), adult diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).

There are no approved CAR-T treatments in Australia for solid cancers. However, research is underway at Peter Mac in CAR T-cell treatment of solid cancers.  Please see ClinicalTrials.gov for further information.

CAR T-cell therapy is distinct from, and does not replace, allogeneic (from a donor) stem cell transplant. Find out more information on allogeneic transplants. 

Access

Regulatory approval

The Therapeutic Goods Administration (TGA) has approved the following CAR T-cell therapies for use in Australia:

  • Kymriah® (tisagenlecleucel)
    • Approved for:
      • Paediatric and adolescent ALL(post-transplant) or in second or later relapse
      • Adult relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy
  • Yescarta® (Axicabtagene ciloleucel)
    • Approved for:
      • Adult relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
  • Tecartus® (brexucabtagene autoleucel)
    • Approved for:
      • Adult relapsed or refractory mantle cell lymphoma (MCL), who have received two or more lines of therapy, including a BTK inhibitor (unless ineligible or intolerant to treatment with a BTK inhibitor)

Funding approval

CAR T-cell therapy is fully funded by the Australian government for the following indications:

  • Paediatric and adolescents up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) in relapse post-transplant, or in second or later relapse (Kymriah, Yescarta)
  • Adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy (Kymriah)

These funding schemes are based on recommendations from the Medical Services Advisory Committee.

Treatment with other approved CAR T-cell therapies or for other indications are not subsidised by the Australian government.

For any queries related to patient eligibility for CAR T-cell therapy or how patients can access this treatment, please email us at: [email protected]

Clinical trials

We continue to look for new uses of CAR T-cell therapy in clinical trials, and we are looking to enrol specific patients into current and upcoming clinical trials in Leukaemia, Lymphoma, Myeloma and solid cancers. For clinical trial availability email: [email protected] or visit ClinicalTrials.gov.

Please discuss with your haematologist or oncologist to assess if CAR T-cell therapy is an appropriate therapy for your disease.