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- Ensaio Clínico NCT05436223
Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human CD19 Targeted T Cells Injection (CD19 CAR-T) Therapy for R/R B-NHL.
Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Xuedong Sun, M.D.
- Número de telefone: +8615811287219
- E-mail: sunxuedong@dashengbio.com
Locais de estudo
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recrutamento
- Zhongshan Hospital, Fudan University
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Contato:
- Peng Liu, M.D. & Ph.D.
- Número de telefone: 0086-021-60267405
- E-mail: liu.peng@zs-hospital.sh.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:Subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma
- Age≥18 years old,gender is not limited;
- Expected survival > 12 weeks;
- ECOG score 0-2;
- B-cell non-Hodgkin's lymphoma confirmed by cytology or histopathology according to the 2016 World Health Organization (WHO) classification and diagnostic criteria, including: diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed filter Alveolar lymphoma (TFL) and high-grade B-cell lymphoma (HGBCL);
Pathology demonstrated that B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
- Relapsed and refractory B-cell non-Hodgkin's lymphoma, after standard first-line treatment and at least 2 courses of second-line treatment without remission and relapse (the previous use of CD20-targeted drugs and anthracyclines were needed);
- Relapse of B-cell non-Hodgkin lymphoma after stem cell transplantation, regardless of previous treatments.
- The venous access required for collection can be established and leukepheresis can be carried according to the judgement of investigators, satisfying hemoglobin≥80g/L, neutrophils ≥1.0×10^9/L, platelets ≥75×10^9 / L;
- According to the Lugano 2014 criteria, there should be at least one measurable tumor lesion;
Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum creatinine≤1.5×ULN or creatinine clearance rate≥50mL/min (GockcroftGault formula);
- Cardiac ejection fraction >50%, no clinically significant pericardial effusion detected, no clinically significant pleural effusion detected;
- Baseline blood oxygen saturation>92%;
- Total bilirubin≤1.5×ULN(Gilbert syndrome≤5×ULN);
- ALT and AST≤3×ULN (AST and ALT ≤5×ULN in patients with liver metastases);
- Able to understand and sign the Informed Consent Document.
Exclusion Criteria:Any one of the following conditions cannot be selected as a subject:
- Malignant tumors other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and high-grade B-cell lymphoma (HGBCL) within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection ;
- Subjects with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and positive peripheral blood hepatitis B virus (HBV) DNA titers (higher than the upper limit of the normal range of the investigative site); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human Immunodeficiency Viral (HIV) antibody positive; syphilis positive;
- Any uncontrolled systemic diseases, including but not limited to active infection (except for localized infection), uncontrolled angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- Any other uncontrolled active disease that precludes participation in the trial;
- Any circumstances that the investigator believes will compromise the safety of the subject or interfere with the purpose of the study;
- Pregnant or lactating woman, or planned pregnancy during treatment or within 1 year after treatment, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
- Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment (except uncomplicated urinary tract infection or upper respiratory tract infection);
- Subjects who were receiving systemic steroid treatment within 14 days before enrollment and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use); or subjects who received any systemic anti-tumor therapy ( except for local anti-tumor therapy) ;
- Subjects who have received CAR-T treatment or other gene-modified cell therapy before enrollment;
- Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
- Subjects who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
- Subjects who are considered unsuitable to participate in this trial by the investigator.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Human CD19 Targeted T Cells Injection
Single administration:2.0×10^6
CAR+T/kg
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A single dose of predetermined level CAR-positive T cells will be infused.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Overall response rate (ORR) at 3 months post infusion
Prazo: 3 months post infusion
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ORR is defined as proportion of subjects who achieved Partial remission(PR) or better at 3 months (D90±7) post infusion as assessed by an independent review committee (IRC) based on Lugano 2014 criteria.
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3 months post infusion
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Duration of remission (DOR) after administration
Prazo: 2 years post infusion
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DOR refers to the time from the first assessment of complete response or partial response to the first assessment of disease progression or death from any cause.
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2 years post infusion
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Progression-free Survival (PFS) after administration
Prazo: 2 years post infusion
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PFS refers to the time from the start of cell infusion to the first assessment of tumor progression or death from any cause.
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2 years post infusion
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Overall Survival (OS) after administration
Prazo: 2 years post infusion
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OS refers to the time from cell infusion to death due to any cause.
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2 years post infusion
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Disease control rate (DCR)
Prazo: 2 years post infusion
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The best overall response is the ratio of partial response(PR) or complete response(CR) or stable disease(SD) patients to the total number of cases.
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2 years post infusion
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Safety evaluation
Prazo: 2 years post infusion
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The occurrence and outcome of adverse events evaluated by physical examination, laboratory examination, electrocardiogram, imaging scan, etc.
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2 years post infusion
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Pharmacokinetic (PK) parameters: Maximum CAR level inperipheral blood
Prazo: 2 years post infusion
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The highest concentration of Human CD19 Targeted T Cells Injection amplified in peripheral blood after infusion (Cmax) .
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2 years post infusion
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Pharmacokinetics(PK) parameters: Time to peak CAR level in blood (Tmax)
Prazo: 2 years post infusion
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The time to reach the highest concentration of Human CD19 Targeted T Cells Injection in peripheral blood after infusion (Tmax) .
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2 years post infusion
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Pharmacokinetics(PK) parameters: 28-day Area under the curve of the CAR level in blood(AUC0-28)
Prazo: 2 years post infusion
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The 28-day area under the curve of Human CD19 Targeted T Cells Injection in peripheral blood after infusion(AUC0-28d).
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2 years post infusion
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Pharmacodynamic (PD) parameters
Prazo: 2 years post infusion
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The clearance degree of CD19 positive B cells in peripheral blood at respective time point.
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2 years post infusion
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HRAIN01-NHL01-Ⅱ
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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