Álvaro Urbano Ispizua, Head of Hematology at the Barcelona Clinic.
The Hospital Clinic of Barcelona keep betting on him growth of the CAR-T therapies against tumor cells and this time it is close to starting a new clinical trial with the ARI 0003. As he has stated in Medical Writing the director of the Institute of Hemato-Oncology of the Hospital Clínic, Alvaro Urbano Ispizua“in a few months we will be able to formally apply for the clinical trial authorization to Spanish Medicines Agency (Aemps) to see if we can start treating patients after the summer“.
The Hospital Clínic team has already had a first contact with the Aempswhich has considered correct the approach proposed by the Barcelona medical center. Despite this, the Agency has requested to extend the preclinical studies and make changes to quality controlswhich are currently being modified.
It is estimated that the number of patients to be included in the future clinical trial is 30. “Recruitment will be quick thanks to the hospitals what collaborate with the study that are the University Hospital Complex of Santiago (CHUS), the Ramón y Cajal University Hospital yel Virgen de la Arrixaca University Clinical Hospital, Although we will try to get some more. These are patients who have a need what is not covered with current treatments. Depending on the efficacy and toxicity results, we will go in one direction or another”, explains the director of the Hematology-Oncology Institute.
The new therapy, aimed at three different groups of patients
This new therapy consists of a combination the ARI 0001 and the ARI 0002 to deal more effectively with the lymphoma. As stated by Urbano, “the ARI 0001 is directed against a diana known as the CD19 and the ARI 0002 vs. BCMA. There is a large number of lymphomas that express both targets, so with this new CART we believe that it can become more effective than CAR-T 19usual for lymphoma treatment”.
The hypothesis of the new work being carried out at the Barcelona hospital is that, in the words of Urbano, “for these patients who have a low density of target 19 at entry or at relapse, giving them a CAR-T that attacks both BCMA and CD19 may be of particularly effective”.
The patients chosen to carry out the treatment with ARI 0003 will be a total of three different groups. Urbano affirms that the therapy will be administered to “those who suffer from lymphoma and there is currently no commercial CAR-T for them, such as the burfitt linfoma and patients who have relapsed after a CAR-T 19. There is also a third group of patients who suffer from different subtypes of very rare lymphoma. One subtype specifically that we want to add in the study is that of patients with HIV positive”.
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“We will try to ensure that the treatment is also for HIV-positive patients” |
The preparation of these new CAR-Ts will later count on the collaboration of the Production Center for Advanced Cellular Therapies of Galiciawhich once fully equipped will be incorporated into the clinical trial as production center. On the other hand, the specialist confirms that the hospitals that will collaborate with the contribution of patients will also “administer the new therapy. It will be a clinical trial open to other hospital centers.”
Ari 0001 awaits a response from the EMA
The first Spanish public CART approved by Aemps, the ARI 0001 for lymphoblastic leukemia who received the hashtag ‘prime‘ by the EMA (European Medicines Agency), is still waiting for a response to see if it finally receives centralized authorization.
“The Head of the Clinic’s Oncoimmunotherapy unit, Julio Delgadoand the regulatory manager of the Clinical Pharmacology Service, Sara Varea, they are doing a tremendous job to prepare all the documentation that the EMA asks for. A 25 percent of the drugs via prime finally receive the authorization by the EMA. There is 75 percent that they deny us. Another factor to take into account is that it is the first time that an academic institution accesses this way. We have fewer resources and experience”, Urban explains.
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