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O Instituto Butantan e o Hemocentro de Ribeirão Preto oficializaram o início do ensaio clínico de fase 1 da terapia celular CAR-T contra dois tipos de câncer que afetam o sangue: leucemia linfoide aguda de células B e linfoma não Hodgkin de células B. Uma cerimônia realizada no Hemocentro marcou o início da operação do Núcleo de Terapia Avançada (Nutera) de Ribeirão Preto, onde a tecnologia está sendo desenvolvida, com a presença da ministra da Saúde, Nísia Trindade, e os secretários de estado da Saúde, Eleuses Paiva, e de Ciência e Tecnologia e Inovação, Vahan Agopyan.
A instalação de ponta, construída com o apoio do Butantan e inaugurada em 2022, será responsável pelo processamento das células CAR-T utilizadas no estudo, que incluirá 81 pacientes, crianças e adultos, recrutados em cinco hospitais do estado de São Paulo: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HC-FMRP-USP), em Ribeirão Preto; Hospital das Clínicas da Universidade Estadual de Campinas (HC-UNICAMP), em Campinas; e Hospital das Clínicas da Faculdade de Medicina da USP (HC-FMUSP), Beneficência Portuguesa e Hospital Sírio Libanês, na capital paulista. Serão incluídos na pesquisa indivíduos que não tiveram resposta ou apresentaram recidiva da doença após tratamentos convencionais, como quimioterapia e transplante de medula óssea.
Também participaram da cerimônia de lançamento do estudo clínico o diretor do Instituto Butantan, Esper Kallás, o superintendente geral da Fundação Butantan, Marcio Lassance, e o diretor-presidente do Hemocentro de Ribeirão Preto, Rodrigo Calado.
“O que temos aqui hoje é um exemplo do melhor que São Paulo pode oferecer, de competência e dedicação em ciência para trazer produtos para a saúde pública. O Instituto Butantan está trabalhando de forma coordenada com o Hemocentro e a USP para oferecer gratuitamente uma terapia avançada de alto custo pelo SUS [Sistema Único de Saúde]. Essa é a nossa missão”, afirmou o diretor do Instituto Butantan, Esper Kallás.
A CAR-T é um tratamento inovador contra o câncer que consiste em modificar geneticamente os linfócitos T (células de defesa) do paciente a fim de que consigam combater as células tumorais. Um dos grandes desafios do câncer é justamente a incapacidade do sistema imune de reconhecer as células doentes. No exterior, a terapia pode custar até US$ 500 mil por paciente, o equivalente a R$ 2,5 milhões.
“A terapia celular vai se consolidar como importante instrumento a favor da saúde pública e do combate a diferentes doenças. A união das competências de pesquisa e desenvolvimento da USP e do Hemocentro e de produção e inovação do Butantan certamente permitirá que esse tratamento seja disponibilizado para mais pessoas”, destacou a ministra da Saúde, Nísia Trindade.
O estudo clínico conta com suporte técnico e regulatório da Agência Nacional de Vigilância Sanitária (Anvisa), por meio de edital para impulsionar o desenvolvimento de terapias avançadas. Em dezembro, o projeto recebeu recursos do Programa para o Desenvolvimento do Complexo Industrial da Saúde (PROCIS), do Ministério da Saúde.
“Esse é um momento ímpar que representa um grande avanço para o estado e o país. Com o investimento de R$ 220 milhões, hoje temos uma unidade fabril equipada e com colaboradores capacitados, que nos permitirá levar uma nova perspectiva de tratamento e qualidade de vida para os pacientes com câncer”, disse o secretário da Saúde, Eleuses Paiva.
O desenvolvimento de uma terapia avançada por instituições públicas, com produção totalmente nacional, contribui para reduzir custos e viabilizar a inclusão do tratamento no SUS. O câncer é a segunda principal causa de morte no mundo, com cerca de 10 milhões de óbitos anualmente, segundo a Organização Mundial da Saúde (OMS). Os gastos públicos com o tratamento da doença ultrapassam R$ 3 bilhões por ano no Brasil e cerca de US$ 2 trilhões no mundo.
Segundo Rodrigo Calado, diretor-presidente do Hemocentro, a tecnologia é única na América Latina. “Nós conseguimos desenvolver todos os passos aqui: construção dos vetores, modificação genética das células e processamento, e o atendimento aos pacientes, sem depender de nenhuma tecnologia estrangeira. Isso só foi possível pela combinação da ciência produzida na USP, da excelência médica do Hospital das Clínicas e do Hemocentro de Ribeirão Preto, e da qualidade tecnológica do Instituto Butantan.”
O evento contou, ainda, com a presença do presidente do conselho curador da Fundação Butantan, Carmino Antônio de Souza; do diretor da Faculdade de Medicina de Ribeirão Preto da USP, Rui Ferriani; do superintendente do Hospital das Clínicas de Ribeirão Preto, Ricardo Cavalli; e do pesquisador responsável pela unidade paulistana do Nutera, Vanderson Rocha. Na ocasião, as autoridades visitaram o Nutera Ribeirão Preto, onde ocorre a produção das células.
O que é a terapia celular
Na terapia CAR-T, os linfócitos T do paciente são obtidos por meio da coleta de sangue, e posteriormente isolados e multiplicados em laboratório. Então, as células T são modificadas geneticamente para expressar um receptor que reconhece e se encaixa nas células tumorais, tornando-se assim capazes de combatê-las. Depois o paciente recebe as novas células por meio de transfusão de sangue para dar início ao tratamento.
Essa tecnologia é resultado de mais de 60 anos de estudos. No mundo, mais de 10 mil pessoas já foram submetidas ao procedimento e muitas alcançaram remissão completa do tumor. A tecnologia foi aprovada pela agência reguladora dos Estados Unidos, a Food and Drug Administration (FDA), em 2017, após uma década de estudos com resultados positivos em pacientes terminais, e vem sendo administrada em outros países da Europa e da Ásia.
No Brasil, a terapia é desenvolvida no Hemocentro de Ribeirão Preto desde 2019, e já foi utilizada para tratar 20 pacientes com leucemia e linfoma de forma experimental, com uma taxa de eficácia de 80%. Ou seja, a maioria dos indivíduos alcançou remissão do tumor.
Estudos indicam que as células CAR-T continuam circulando no organismo mesmo após o tratamento, reduzindo a chance de recidivas. Foi o que aconteceu com os dois primeiros pacientes a serem tratados nos EUA em 2010, que alcançaram remissão e continuam livres da doença até hoje, segundo artigo publicado na revista Nature.
Sobre o Nutera
O Nutera é fruto da colaboração entre o Instituto Butantan, o Hemocentro e o Hospital das Clínicas de Ribeirão Preto, Hospital das Clínicas da FMUSP e a USP, com apoio de instituições de fomento à pesquisa como Fundação de Amparo à Pesquisa do Estado de São Paulo (Fapesp), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) e Programa Nacional de Apoio à Atenção Oncológica (PRONON).
A unidade localizada no Hemocentro de Ribeirão Preto, no campus da USP, foi projetada para atender os participantes do estudo clínico e, futuramente, escalonar a produção das células CAR-T, tornando-se capaz de atender até 300 pacientes por ano.
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