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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 noviembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

160

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Droga: CT204V-CD19 × CD20

Experimental

Otros nombres:
  • CT204V

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Adverse Events(AEs)/Serious Adverse Events (SAEs), Phase 1 of the study.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: Up to 24 months.

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (Complete Response+Partial Response) per Lugano Classification, Phase 1 of the study.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de noviembre de 2026

Finalización primaria (Estimado)

15 de octubre de 2029

Finalización del estudio (Estimado)

15 de octubre de 2029

Fechas de registro del estudio

Enviado por primera vez

6 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • R1055C00001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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 información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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