Hospital Sant Pau's CAR-T therapy successfully passes the phase I trial against Hodgkin and non-Hodgkin T lymphoma

The first trial with a CAR-T immunotherapy drug produced by the Hospital de Sant Pau in Barcelona,

due to its characteristics (it is a CAR-T30 and is called

) and third in the world (in the United States two other centers are testing similar therapies), for the treatment of classic Hodgkin's lymphoma and also for relapsed or refractory non-Hodgkin T CD30+, phase I has been successfully completed, according to the center itself.

With this project, led by Javier Briones, head of the Clinical Hematology Unit of the Sant Pau Hospital Hematology Service and director of the Cellular Immunotherapy and Gene Therapy Research Group of the Sant Paz Hospital Research Institute - IIB-Sant Pau, this Barcelona hospital joins, with its academic and public CAR-T in the clinical development phase, the initiatives to

in which the Hospital Clínic de Barcelona and the Hospital La Peace of Madrid.

In phase I of the trial, previously approved by the Spanish Agency for Medicines and Health Products (AEMPS),

with Hodgkin's lymphoma and T-cell lymphoma, refractory to all approved conventional treatments, have participated.

The patients treated are from different autonomous communities (Catalonia, Andalusia, Asturias, Galicia, Castilian and León and Valencia) and from other European countries (Italy, Austria and Poland).

The results of this phase have just been presented at the Congress of the European Society of Hematology (

) that is being held in Vienna this week, the Hospital de Sant Pau has reported.

This CAR-T 30 is

.

"CAR30 memory T cells have an excellent safety profile and preliminary data show very high efficacy, with 50% of patients having a complete response to treatment with disappearance of the lymphoma. These excellent results are the basis for the study." phase II, whose patients have already started receiving treatment," explained the center.

"It has been

since we started our research in the laboratory. We have been achieving goals such as the design and manufacture of the drug or pre-clinical studies. Now, finishing phase I and verifying in the first clinical trial in Europe to this type of lymphoma, in which half of the patients have achieved complete remission of the cancer, is very gratifying and motivating", stated researchers Ana Carolina Caballero, Laura Escribà Garcia and Carmen Álvarez Fernández, from the Cellular Immunotherapy and Genetics of the Sant Pau Research Institute - IIB Sant Pau.

For over 18 years

Briones has specified, for his part, to this newspaper that CAR-T30 is being tested in people over 18 years of age and that, although all the patients in the phase I trial responded positively and the therapy proved to be safe (

), only half did it completely (total remission), but we must bear in mind that these are patients who have already been treated with all the available alternatives and this is the last option left to them.

In fact, two registered deaths were not due to the innovative treatment, which

, but due to the progression of the disease.

Briones has added another specific characteristic of this medicine from Sant Pau:

;

it is infused fresh after a process that lasts about 10 days from apheresis.

The Research Institute of the Hospital de la Santa Cruz y San Pablo - IIB Sant Pau, in collaboration with the Blood and Tissue Bank of Catalonia, obtained in 2020 the

for the production of a therapeutic medicine advanced.

This certification issued by the AEMPS allows the production and quality control of CAR-T cell drugs in a clean room, equipment specially designed for the development of advanced therapy drugs that allows Sant Pau researchers to offer innovative treatments to their patients.

Briones says that developing this CAR-T in compliance with all the regulations of the AEMPS and the European Medicines Agency (EMA) has not been easy.

"The AEMPS, as it should be, is being informed in all the details. Its level of demand is very high because we must not forget that what we are doing is a medicine that may have unknown side effects and that may be serious", has affirmed he.

The relationship with the AEMPS, due to the fact that it is a public center, is not more or less easy: "

".

The emblematic Barcelona center, as mentioned above, has started

.

Three of them have already been treated and it is planned to open the study to patients from other centers, as was done in phase I.

In addition to this CAR-T30,

.

CAR-T academic, public and, cheaper?

"We are not worried about that, although obviously this CAR-T will be cheaper. What matters to us is reaching patients without therapeutic alternatives, neither CAR-T nor any other type. In other words,

. "

We do not want to compete, but we believe that we can provide knowledge and cure our patients", Briones asserted.

Several organizations and foundations have supported this Sant Pau project: the

have collaborated with the acquisition of an important part of the equipment and the provision of funds for the production of drugs for the first 10 patients.

In this sense, the Josep Carreras Institute acquired two new cell production equipment that has been located in Sant Pau.

To purchase the first, the Josep Carreras Foundation launched a fundraising campaign in 2018 under the title

.

The Josep Carreras Foundation has contributed more than two million euros to promote the start of the phase I trial and will continue to give its support in phase II.

Other organizations such as the Carlos III Health Institute (through its funds for

), the "La Caixa" Foundation and the Spanish Association Against Cancer (AECC) have also supported the development of this clinical research project.

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