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CD19-directed CAR T cell therapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL)
CAR-T cell therapy explained (CLL)
What is chronic lymphocytic leukaemia (CLL)? Who is CAR-T cell therapy suitable for? How does CAR-T cell therapy work, and what does outpatient treatment involve at the therapy centre at Heidelberg University Hospital? We explain all of that in this video.
CD19-directed CAR T cell therapy for patients with relapsed or refractory chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) usually follows an indolent course without affecting life expectancy and quality of life to a relevant extent. However, in a small minority of patients the disease behaves aggressively and develops resistance against modern drugs such as Bruton tyrosine kinase inhibitors (BTKi, e.g. acalabrutinib and zanubrutinib) and BCL-2 inhibitors (BCL2i, e.g. venetoclax). These so called double-refractory patients could benefit from CAR T cell therapy.
CAR-T cell therapy for CLL in Heidelberg
CAR-T cell therapy is a modern form of immunotherapy in which the body’s own immune cells are specifically modified so that they can recognise and attack cancer cells. At Heidelberg University Hospital, this therapy is also used for selected patients with chronic lymphocytic leukaemia (CLL).
Heidagen-lecleucel is Heidelberg’s own CAR-T cell product for the treatment of CLL. It is manufactured directly at Heidelberg University Hospital.
What are CAR-T cells?
CAR T-cells are immune cells that are genetically engineered to recognize specific structures on the surface of cancer cells. This enables CAR T-cells to kill cancer cells. Unlike drug-based CLL treatments, CAR T-cell therapy is always a one-hit treatment, meaning that after an approximately two-week inpatient treatment and monitoring period (optional partly outpatient), the actual therapy is completed. However, outpatient follow-up care is provided to monitor tolerability and treatment efficacy according to a structured schedule.
CD19 CAR T-cell products manufactured by industry are approved in Europe for several other leukemias and cancers of the immune system. CAR T-cells for CLL, however, are available in Germany outside of clinical trials only at Heidelberg University Hospital.
Our CAR T-cell product is heidagen-lecleucel, a novel CD19-directed CAR T-cell product that has demonstrated excellent tolerability and promising efficacy in patients with advanced CLL. It is manufactured at Heidelberg University Hospital and is authorized by Germany’s federal competent authority, the Paul-Ehrlich-Institut, for use in adult patients with CLL.
Who could be eligible for CAR T-cell therapy?
CAR-T cell therapy is not an option for every patient with CLL. It is being evaluated in particular for advanced disease, when previous treatments have not been sufficiently effective or the disease has recurred.
Whether treatment with Heidagen-lecleucel is possible and appropriate depends on various factors. These include, among other things, the patient’s medical and treatment history, overall health, and certain characteristics of the CLL. Eligibility for the therapy is therefore always assessed on an individual basis by the specialized treatment team at Heidelberg University Hospital.
How does CAR-T cell therapy work for CLL?
At the start of treatment, T-cells are collected from the patient’s blood. These cells are then processed into CAR-T cells in the specialised laboratory at Heidelberg University Hospital. A preparatory treatment is carried out
before the actual CAR-T cell infusion. The CAR-T cells produced are then administered as a single infusion.
The pre-treatment can be carried out on an outpatient basis. Patients are admitted to hospital for the CAR-T cell therapy itself and the subsequent monitoring.
How long does the treatment take?
The hospital stay usually lasts around two to three weeks. The exact duration depends on the individual’s progress. Outpatient examinations and check-ups take place before and after the hospital stay.
Will the treatment take place as an inpatient or outpatient procedure?
The CAR-T cell therapy itself takes place on an inpatient basis at Heidelberg University Hospital. Preparation and follow-up care are provided on an outpatient basis.
This enables patients to be specifically prepared before treatment and to continue to receive close monitoring after their inpatient stay has ended.
Where are CAR-T cells produced?
Heidagen-lecleucel is manufactured directly at Heidelberg University Hospital. The patient’s T-cells, which have been harvested beforehand, are processed in our specialised GMP laboratory for cellular immunotherapy and further developed into CAR-T cells.
Further information on the manufacturing process can be found on the website of the Cell and Immunotherapy Research Division.
Treatment at Heidelberg University Hospital
CAR-T cell therapy for CLL is carried out by a specialist team. From assessing whether treatment is suitable, through to the production of the CAR-T cells, inpatient treatment and follow-up care, patients are supported at Heidelberg University Hospital.
How to get in touch
We review your documents and advise which additional information may be needed.
We discuss options, eligibility, and a potential treatment pathway.