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Anvisa (National Health Surveillance Agency)
ratifies the safety of CAR-T therapy and authorizes
the continuation of the clinical trial
After approval, the clinical trial will be able to recruit and treat patients with B-cell acute lymphoblastic
leukemia or B-cell non-Hodgkin's lymphoma at partner centers beginning in 2025.
In the first phase, the Carthedrall clinical trial recruited and treated patients only at the FMRP Hospital das Clínicas and the Hospital das Clínicas of the USP Faculty of Medical Sciences – Photo: HC-FMRP Blood Center Advisory
The National Health Surveillance Agency (Anvisa) approved the safety report for the first phase of the Carthedrall CAR-T cell therapy clinical trial, which is being conducted at the Blood Center of Ribeirão Preto in collaboration with the Butantan Institute and authorized it to proceed to the second phase. The favorable opinion was officially released on Wednesday (12/11) by the Brazilian health authority.
CAR T-cell therapy involves the genetic modification of immune system cells called lymphocytes that circulate in the bloodstream. These lymphocytes are “trained” in the laboratory to recognize a specific target and then returned to the patient’s bloodstream.
The Carthedrall clinical trial aims to treat 81 people with refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell non-Hodgkin’s lymphoma – when cancer stops responding to therapy or comes back very quickly – at five Brazilian referral centers. The goal is to evaluate the safety and efficacy of CAR-T cells. The study is funded by the Ministry of Health through the Program for the Development of the Health Industrial Complex (Procis).
In the initial phase, patients were recruited and treated at the Hospital das Clínicas of USP’s Faculty of Medical Sciences of Ribeirão Preto (HC-FMRP). According to Diego Villa Clé, Coordinator of the Center for Advanced Therapies (Nutera) at the Blood Center of Ribeirão Preto and principal investigator of the Carthedrall study, “all patients treated showed a response to the CAR-T cells and the procedure was safe. There were no serious side effects”.
Anvisa’s approval and clearance for the second phase of the study allows the partner centers – Hospital das Clínicas (HC) of FMUSP, Beneficência Portuguesa, Hospital Sírio -Libanês, based in São Paulo (SP), and Hospital de Clínicas de Campinas at Unicamp – to recruit and treat patients starting January 2025.

Diego Villa Clé - Photo: Linkedin
The goal is to offer the therapy free of charge on the Unified Health System (SUS) in the future. Rodrigo Calado, Chief Executive Officer of the Blood Center of Ribeirão Preto and full professor of Hematology at FMRP, explains that there are currently treatments with CAR-T cells available commercially in Brazil, but they are unfeasible from an economic point of view. “Our job is to develop a completely national technology so that this treatment is accessible to all patients treated by the SUS,” he says.
Treatment with CAR-T cells has been carried out in Brazil since 2019, in collaboration between the Blood Center of USP’s Faculty of Medical Sciences of Ribeirão Preto and the Butantan Institute – Photo: HC-FMRP Blood Center Advisory
Pioneering CAR-T cells in Latin America
For almost a decade, the Blood Center of Ribeirão Preto has been dedicated to cell therapies, supported by the Cell Therapy Center (CTC), one of the Research, Innovation and Dissemination Centers (Cepids) of the São Paulo State Research Foundation (Fapesp), based at USP. The technology for producing CAR-T cells was developed at the institution and, as a result, the first treatment in Latin America was carried out in Ribeirão Preto in 2019.
The initial results led to the continuation of the initiative and the creation of a partnership between the Blood Center of Ribeirão Preto, USP and the Butantan Foundation, with support from the Fapesp and CNPq (National Council for Scientific Research) funding agencies. The collaboration resulted in the creation of Nutera in Ribeirão Preto. The “cell factory” is already operating and will be responsible for meeting patient demand.
The CAR-T currently being produced at Nutera is specific for a target called CD19, a protein found only in B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin’s lymphoma. Therefore, this immunotherapy is not effective in other types of cancer.
Pushing the boundaries in healthcare
In addition to producing anti-CD19 CAR-T cells for treating leukemia and lymphoma, Nutera is looking to expand its research into new cell therapies. The focus is on using the immune system itself to fight disease.
In October of this year, more than R$7 million was approved by the CNPq to carry out a clinical trial focused on autoimmune diseases. The project, which will treat patients with systemic lupus erythematosus with CAR-T cells, was approved with the highest score among the participants of the “Precision Genomics and Public Health” call, promoted by CNPq, Genomas Brasil, the Ministry of Health and the Federal Government, and is expected to start in the next few years.
The Blood Center of FMRP has a “cell factory”, Nutera, which is part of the largest cancer treatment program in Latin America – Photo: HC-FMRP Blood Center Advisory
The patients will be treated at two institutions: the Hospital das Clínicas de Ribeirão Preto (HC-FMRP) of USP, coordinated by Maria Carolina de Oliveira Rodrigues, coordinator of the FMRP Graduate Studies Program in Basic and Applied Immunology, and Paulo Louzada Junior, vice-coordinator of the Cepid-Fapesp Inflammatory Diseases Research Center and Hospital das Clínicas de São Paulo (HC-FMUSP), by Eloisa Bonfá, coordinator of the Network of University Centers for the Dispensing of High-Complexity Medicines (CEDMAC), and Luciana Seguro, rheumatologist and member of the Lupus Commission of the Brazilian Society of Rheumatology.
More information on the study can be found at:www.hemocentro.fmrp.usp.br/terapia/
*With information from the Press Office of Cell Therapy Center (CTC) of USP
**Intern under the supervision of Moisés Dorado
English version: Nexus Traduções

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