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- Ensaio Clínico NCT03018093
A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL
A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose expansion trial).Subjects will be divided into low-dose group, medium-dose group and high-dose group.Additional patients will be enrolled to confirm the optimal dose
Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Li Yu
- Número de telefone: 010-66937644
- E-mail: liyu301@vip.163.com
Locais de estudo
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Beijing
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Beijing Shi, Beijing, China
- Recrutamento
- Chinese PLA General Hospital
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Contato:
- Li Yu
- Número de telefone: 010-66937644
- E-mail: liyu301@vip.163.com
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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:
- Age 14-75 years old, male or female.
- Volunteered to participate in this study and signed written informed consent form.
- Histologically diagnosed as CD19+B-ALL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2016 version 1).
Relapsed or refractory CD19+B-ALL (meet one of the following conditions)
- Refractory as defined not achieving a CR(complete remission, morphology<5% blasts) after two cycles of standard chemotherapy regimen.
- Duration of remission ≤ 12 months after the first induction chemotherapy regimen.
- Refractory disease after one or more salvage therapies.
- Two or more Bone Marrow relapse.
- Morphological disease in the bone marrow (≥ 5% blasts).
- Subjects with Philadelphia chromosome negative(Ph-) disease, or subjects with Philadelphia chromosome positive(Ph+) disease that are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated are eligible.
- No salvage chemotherapy therapy within 4 weeks prior to C-CAR011 therapy.
- No immunosuppressant(including but not limited to systemic corticosteroid therapy) within 4 weeks prior to C-CAR011 therapy.
- No antibody therapy within 4 weeks prior to C-CAR011 therapy.
- Normal cardiac function confirmed by ECHO with left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
- Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
- No contraindications of peripheral blood apheresis.
- Expected survival ≧ 3 months.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- History of severe allergic disease or allergic to one or more drugs.
- Any kind of these laboratory testing: serum total bilirubin≧1.5mg/dl, serum albumin≦35g/L, ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, platelets≦50×109/L.
- Extramedullary disease.
- Relapsed disease after allogeneic hematopoietic stem cell transplantation.
- Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis.
- Subjects with concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
- Subjects with grade III or above severe hypertension(WHO/ISH Guidelines for the Management of Hypertension, 1999).
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months prior to enrollment.
- Subjects with class III and IV heart failure according to the NYHA Heart Failure Classifications;
- History of QT prolongation with clinically significant arrhythmias.
- History of epilepsy or other central nervous system disorders.
- History or presence of any central nervous system leukemia(CNS3, CNS4) disorder , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
- Autoimmune diseases needing treatment, or immune deficiency or other diseases needing immunosuppressive therapy.
- Subjects with TKIs therapy (Ph+ ALL) within 1 week prior to enrollment.
- Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis allowed) or currently receiving intravenous antibiotic therapy and has received intravenous antibiotic therapy within one week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible.
- Used any genetically modified T cell therapy.
- Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Ommaya reservoirs and dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted.
- Live vaccine≦4 weeks prior to enrollment.
- Known infection with HIV, TB, hepatitis B (including carriers) or hepatitis C virus (anti-HCV positive).
- History of alcohol addiction , drug abuse or mental disease.
- Participated in any other clinical trial within three months prior to enrollment.
- Women who are pregnant or lactating or have breeding intent within 6 months.
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
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: C-CAR011
In day 0, 1 and 2, CAR011 cells will be intravenous infused at the 10%, 30% and 60% ratio respectively.
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CD19-targeted chimeric antigen receptor T cells
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Dose-limiting toxicity (DLT)
Prazo: 30 days
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30 days
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Overall response rate (ORR)
Prazo: 8 weeks
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8 weeks
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Sobrevida global (OS)
Prazo: 24 semanas
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24 semanas
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Minimal residual disease negative remission rate(MRD-)
Prazo: 8 weeks
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Li Yu, Chinese PLA General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- CBMG2016003
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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