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A Modular, Phase I/II Study to Evaluate CT204V-CD19 x CD20 in Participants With Relapsed or Refractory B-Cell Malignancies. (CT204V)

6 de novembro de 2026 atualizado por: AstraZeneca

A Modular, Phase I/II, Open-label, Single-arm, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of CT204V-CD19 × CD20, an In Vivo Lentiviral Vector Gene Therapy Generating Dual Targeting Anti-CD19/CD20 Chimeric Antigen Receptor (CAR)-T Cells in Participants With Relapsed or Refractory B-Cell Malignancies

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CT204V-CD19 × CD20, a dual targeting in vivo gene therapy generating anti-CD19/CD20 CAR-T cells in participants with R/R B-cell malignancies.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

160

Estágio

  • Fase 2
  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • * Participants must be at least 18 years of age.
  • * Confirmed expression of CD19 and/or CD20.
  • * Histologically confirmed and measurable disease for all disease subtypes.
  • * ECOG performance status 0 or 1.
  • * Adequate organ and bone marrow function.
  • * Body weight of at least 45 kg.
  • * Contraceptive/barrier requirement consistent with local regulations.
  • * Capable of giving signed informed consent.

Exclusion Criteria:

  • * History of malignancy unless disease-free for ≥ 3 years, with exceptions.
  • * Active CNS involvement by malignancy.
  • * History of cardiac lymphoma involvement.
  • * Richter's transformation of CLL.
  • * Ongoing or impending oncologic emergency.
  • * Active uncontrolled bacterial, viral, or fungal infection.
  • * Active hepatitis B or C.
  • * Positive HIV test.
  • * Positive HTLV-1/2 antibody test.
  • * Ongoing non-hematologic toxicities from prior therapy.
  • * History of any grade IEC-HS, Grade ≥ 3 CRS, or Grade ≥ 2 NT during prior CAR-T cell therapy.
  • * History of allogeneic stem cell or solid organ transplantation.
  • * Primary immunodeficiency disorder.
  • * History of specific autoimmune diseases.
  • * Significant neurological or psychiatric conditions.
  • * Receipt of prior treatment containing VSV-G.
  • * Receipt of certain therapies within specified washout periods.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

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
Experimental: CT204V-CD19 × CD20

Participants will receive CT204V-CD19 × CD20, an In Vivo Lentiviral Vector Gene Therapy, generating dual targeting anti-CD19/CD20 Chimeric Antigen Receptor (CAR)-T cells.
Medicamento: CT204V-CD19 × CD20

Experimental

Outros nomes:
  • CT204V

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Prazo: Up to 15 years

Incidence and severity of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Up to 15 years
Number of Dose-Limiting Toxicities (DLTs) events during dose escalation, Phase 1 of the study.
Prazo: Up to 28 days.

Incidence of Dose-Limiting Toxicities (DLTs) during dose escalation, Phase 1 of the study.
Up to 28 days.
Number of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.
Prazo: Up to 1 year.

Incidence of AEs leading to dose reduction, withdrawal, interruption, Phase 1 of the study.
Up to 1 year.
Number of AEs leading to death, Phase 1 of the study.
Prazo: Up to 15 years

Incidence of AEs leading to death, Phase 1 of the study.
Up to 15 years
Number of AESI (adverse events of special interest), Phase 1 of the study.
Prazo: Up to 15 years

Incidence of AESI (adverse events of special interest), Phase 1 of the study.
Up to 15 years
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
Prazo: Up to 24 months.

To assess the efficacy based on ORR (CR+PR) events.
Up to 24 months.
Complete Response (CR) rate, Phase 2 of the study.
Prazo: Up to 24 months.

To assess the efficacy based on CR rate.
Up to 24 months.
Best Overall Response (BOR), Phase 2 of the study.
Prazo: Up to 24 months.

To assess the efficacy based on BOR rate.
Up to 24 months.
Duration of Response (DoR), Phase 2 of the study.
Prazo: Up to 24 months.

To assess the efficacy based on DoR rate.
Up to 24 months.
Duration of Complete Response (DoCR), Phase 2 of the study.
Prazo: Up to 24 months.

To assess the efficacy based on DoCR rate.
Up to 24 months.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, as assessed by the investigator.
Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, as assessed by the investigator.
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, as assessed by the investigator.
Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, as assessed by the investigator.
Up to 24 months post-infusion.
Frequency and severity of AEs/SAEs
Prazo: Up to 15 years

To further characterize the safety of CT204V with selected prophylaxis regimen.
Up to 15 years
Complete Response (CR) rate, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V per CR rate, as assessed by the investigator.
Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on BOR, as assessed by the investigator.
Up to 24 months post-infusion.
Duration of Response (DoR), Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on DoR. as assessed by the investigator.
Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity ofCT204V based on DoCR, as assessed by the investigator.
Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, as assessed by the investigator.
Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, as assessed by the investigator.
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Cmax/Clast, as assessed by the investigator.
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter Tmax/Tlast.
Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.
Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, as assessed by the investigator.
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter AUC0-28/AUClast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR transgene PK parameter AUC0-28/AUClast, central read.
Up to 24 months post-infusion.
Incidence of Anti-Drug Antibodies (ADA), Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the humoral immunogenicity of CT204V and its vector components based on incidence of humoral immunogenicity (ADA) against CT204V and/or vector components, central read.
Up to 24 months post-infusion.
Complete Response (CR) rate, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V per CR rate, central read.
Up to 24 months post-infusion.
Best Overall Response (BOR), Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on BOR, central read.
Up to 24 months post-infusion.
Duration of Response (DoR), Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V based on DoR, central read.
Up to 24 months post-infusion.
Duration of Complete Response (DoCR), Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity ofCT204V based on DoCR, central read.
Up to 24 months post-infusion.
Viral vector PK parameter Cmax/Clast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Cmax/Clast, central read.
Up to 24 months post-infusion.
Viral vector PK parameter Tmax/Tlast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter Tmax/Tlast, central read.
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Cmax/Clast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels in peripheral blood per CAR, transgene PK parameter Cmax/Clast, central read
Up to 24 months post-infusion.
Cellular Kinetics (CK) of CT204V CAR transgene parameter Tmax/Tlast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, central read.
Up to 24 months post-infusion.
Viral vector PK parameter AUClast, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood per PK parameter AUClast, central read.
Up to 24 months post-infusion.
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

To evaluate the preliminary antitumor activity of CT204V. ORR (CR+PR) per Lugano Classification based on ORR, central read.
Up to 24 months post-infusion.
Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, Phase 2 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V CAR transgene levels (copies/μg gDNA) in peripheral blood, central read.
Up to 24 months post-infusion.
Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, Phase 1 of the study.
Prazo: Up to 24 months post-infusion.

Quantification of CT204V viral vector genomes (viral titer) in peripheral blood, central read, as assessed by the investigator.
Up to 24 months post-infusion.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

9 de novembro de 2026

Conclusão Primária (Estimado)

15 de outubro de 2029

Conclusão do estudo (Estimado)

15 de outubro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R1055C00001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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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