Vall d'Hebron shows long-term safety of CAR-T therapy in aggressive lymphoma patients

A study coordinated by Vall d'Hebron has evaluated the long-term effects of CAR-T therapy in patients with an aggressive type of lymphoma. The results, published in the journal JAMA Network Open, show that the treatment has a favourable safety profile, although continued monitoring of patients is necessary, as adverse effects can occur even years later. The study is led by the Clinical Pharmacology group of the Vall d'Hebron Research Institute (VHIR), the Experimental Haematology group of the Vall d'Hebron Institute of Oncology (VHIO), and the Clinical Pharmacology and Haematology Services of the Vall d'Hebron University Hospital. 

B-cell non-Hodgkin's lymphoma is a type of cancer that affects the lymphatic system, specifically the B-lymphocytes, which are responsible for producing antibodies. Although there are several treatment options, many patients do not successfully respond to conventional therapies. In these refractory or relapsed cases, CAR-T cell therapy has become a promising option to achieve prolonged remission.  

It is important to understand the potential adverse effects of this innovative therapy, both in the short and long term. In recent years, numerous studies have analysed the toxicity of CAR-T therapy during the first few weeks, but there is a need for further studies to assess safety after months or even years.  

To this end, Vall d'Hebron has studied the adverse effects that appear in patients with B-cell non-Hodgkin's lymphoma at least three months after CAR-T therapy. Between 2018 and 2022, 172 patients from six hospitals in the state were followed up for between eight and 23 months, depending on the case. "Some patients may experience late adverse effects, although most of these can be managed clinically without serious complications. This work confirms that CAR-T therapy has a good safety profile", says Dr Antònia Agustí, head of the Clinical Pharmacology Service at Vall d'Hebron University Hospital and of the Clinical Pharmacology group at VHIR.  

Among the most common adverse effects are infections, such as COVID-19, and a reduction in the number of neutrophils, a type of immune system cell important for fighting infections. Other blood alterations, such as a reduction in the number of platelets, are common in the first months, but tend to improve after the sixth month.  

On the other hand, dermatological, neurological and cardiovascular effects are observed, although they are less frequent and generally mild. Finally, four patients developed other types of cancer after treatment.  

Based on the results, the team leading the project stresses the importance of continued follow-up of patients after treatment. "This study helps us to understand how to improve patient care after CAR-T therapy to detect and manage possible long-term adverse effects", explains Dr. Pere Barba, head of the Advanced Therapies section of the Haematology Department at Vall d'Hebron Hospital and researcher in Experimental Haematology group at VHIO. 

The study was carried out in collaboration with the Pharmacy Service of the Vall d'Hebron University Hospital, the Health Research Institute of the Gregorio Marañón Hospital, the INCLIVA Health Research Institute of the University Clinical Hospital of Valencia, the University Hospital of Salamanca, the August Pi i Sunyer Biomedical Research Institute (IDIBAPS) of the Hospital Clínic of Barcelona, and the University and Polytechnic Hospital La Fe.