Hospital Sant Pau’s CAR-T therapy successfully passes Phase I trials against Hodgkin’s and non-Hodgkin’s T lymphoma

Updates

Barcelona center publishes results of its self-made immunotherapy drug against these two types of tumors

Javier Briones leads the Sant Pau CAR-T30 project, a pioneer in Europe.
Javier Briones leads the Sant Pau CAR-T30 project, a pioneer in Europe.EM

The first trial with the CAR-T immunotherapy drug, produced by the Hospital de Sant Pau in Barcelona, leading in europe because of its features (this is a CAR-T30 and is called HSP-CAR30) and third in the world (two other centers in the United States are testing similar therapies), for the treatment of classic Hodgkin’s lymphoma as well as for relapsed or refractory CD30+ non-Hodgkin’s lymphoma, successfully Phase I has been completed, as assured by 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 clinical To initiate, with its academic and public CAR-Ts in development stage Produce and treat this type of immunotherapy drugs Which also operates Hospital Clinic in Barcelona and Hospital La Paz in Madrid.

In Phase I of the trial, first approved by the Spanish Agency for Medicines and Health Products (AEMPS), 10 patients have participated With Hodgkin lymphoma and T lymphoma, refractory to all accepted conventional treatments. The patients treated are from different autonomous communities (Catalonia, Andalusia, Asturias, Galicia, Castellano and Leone 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 (EHA2022 Congress) which is being held in Vienna this week, the Hospital de Sant Pau has reported.

This is CAR-T30 Enriched with high proportion of memory T cells, “CAR30 memory T cells have an excellent safety profile and preliminary data show extremely high efficacy, with complete response to treatment with disappearance of lymphoma in 50% of patients. These excellent results are the basis of the study.” Phase II, those whose patients have already started receiving treatment,” the center explained.

“Used to be Very far Ever since we started our research in the lab. We are achieving goals such as drug design and manufacturing or pre-clinical studies. Now, ending phase I and verifying that half of patients achieve complete cancer remission in the first clinical trial in Europe for this type of lymphoma is very gratifying and inspiring”, says researchers Ana Carolina. Caballero, Laura García and Carmen.Loverez Fernandez from the Cellular Immunotherapy and Gene Therapy Research Group of the Sant Pau Research Institute – IIB Sant Pau wrote.

for more than 18 years

Briones, for his part, specified to this newspaper that CAR-T30 is being tested in people over the age of 18 and, however, all patients in the Phase I trial responded positively and the therapy was proven safe. Hui (very low toxicity), only half did it completely (total remission), but we must note that these are patients who have already been treated with all available options and this is the last option left for them.

In fact, two of the registered deaths were not due to the innovative treatment, which administered in a single infusionBut as the disease progresses. Briones from Sant Pau has added another distinctive feature of this drug: does not fit, It is refreshed after aphresis, a process lasting about 10 days.

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 Certificate of Compliance with Good Manufacturing Practices For the production of an advanced medical drug. This certification, issued by AEMPS, allows the production and quality control of CAR-T type cellular drugs in a clean room, tools specifically designed for the development of advanced medical drugs that allow Sant Pau researchers to deliver innovative treatments to their patients. allow to provide.

Briones says that it has not been easy to develop this CAR-T in compliance with all the regulations of AEMPS and European Medicines Agency (EMA). “AEMPS, as it should be, is being communicated in all details. The level of demand for it is very high because we must not forget that what we are doing is a drug that can have unknown side effects and they are serious. Might be”, confirmed. The relationship with AEMPS, due to the fact that it is a public centre, is not more or less easy: “We follow traditional channels, nothing more,

As mentioned above, the symbol center of Barcelona has started Phase II of the trial, which will involve 30 patients, Three of them have already been treated and there are plans to start the study for patients from other centres, as was done in the first phase.

In addition to this CAR-T30, Sant Pau is also working on CAR-19 for different types of lymphoma,

CAR-T Academic, Public and Cheap?

“We’re not worried about that, although clearly this CAR-T will be cheaper. What matters to us is reaching patients without therapeutic options, neither CAR-T nor any other type. ie. , We are interested in meeting an unmet medical need, We don’t want to compete, but we believe we can impart knowledge and heal our patients”, Briones stressed.

This Sant Pau project has been supported by various organizations and foundations: Josep Carreras Leukemia Foundation and Josep Carreras Leukemia Research Institute He has collaborated with the acquisition of a significant part of the equipment and the provision of funds for the production of drugs by the first 10 patients. In this sense, the Josep Carreras Institute acquired two new cell production equipment which are located in Sant Pau. To buy the first, the Josep Carreras Foundation launched a fundraising campaign in 2018 under the title Ajay Sail Factory, The Josep Carreras Foundation has contributed more than two million euros to promote the start of Phase I trials and will continue to support Phase II.

Other organizations such as the Carlos III Institute of Health (through funds for this) independent clinical research), 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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