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El ensayo clínico NCT06542250 (TITANium) para Neoplasias malignas de células B está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Un estudio para evaluar la seguridad, PK, PD y eficacia de AZD5492, un anticuerpo que activa las células T dirigido a CD20 en sujetos con neoplasias malignas de células B en recaída/refractarias (TITANium) Fase I, Fase II 174

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT06542250 (TITANium) está diseñado para estudiar el tratamiento de Neoplasias malignas de células B. Es un estudio intervencionista de Fase I Fase II. Su estado actual es: reclutando. El estudio se inició el 18 de septiembre de 2024, con el objetivo de reclutar a 174 participantes. Dirigido por AstraZeneca, se espera que finalice el 14 de febrero de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
Título oficial

A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)

Condiciones médicas
Neoplasias malignas de células B
Otros ID del estudio
  • TITANium
  • D9960C00001
Número del NCT
NCT06542250
Inicio del estudio (real)
2024-09-18
Última actualización
2026-03-27
Fecha de finalización (estimada)
2028-02-14
Inscripción (prevista)
174
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Estado general
Reclutando
Palabras clave
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Diseño secuencial
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalModule 1: AZD5492 Monotherapy
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Frequency of dose limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, AESIs, and SAEs
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.
SAEs/AEs leading to discontinuation of AZD5492.
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Overall Response Rate (ORR)
The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Complete Response Rate (CR Rate)
The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Duration of Response (DoR)
The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Progression-free Survival (PFS)
The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Overall Survival (OS)
The time from the date of first dose until date of death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Pharmacokinetics of AZD5492: serum concentration of study drug
Maximum observed serum concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).
Area under the plasma concentration-time curve.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: apparent clearance
The volume of plasma from which the study drug is completely removed per unit time.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Terminal elimination half-life.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The number of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The percentage of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos

  • ≥18 years of age;

  • Histologically documented CD20+ mature B-cell neoplasm

    • Large B-cell lymphoma
    • Follicular lymphoma
    • Mantle cell lymphoma
    • Chronic lymphocytic leukemia
    • Small lymphocytic lymphoma

  • Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;

  • ECOG performance status of ≤ 2 (< 2 in EU countries).

The above is a summary, other inclusion criteria details may apply.

  • Any neoplasm histology not specified in the IC section;
  • Active CNS involvement in lymphoma;
  • CNS pathology including but not limited to any history of seizure disorder/epilepsy;
  • Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
  • History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
  • Active and uncontrolled infections;
  • Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.

AstraZeneca logoAstraZeneca772 estudios activos para explorar
Contactos centrales del estudio
Contacto: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
29 Centros del estudio en 10 países
Research Site, Barcelona, 08035, Spain
Reclutando
Research Site, L'Hospitalet de Llobregat, 08908, Spain
Reclutando
Research Site, Madrid, 28040, Spain
Reclutando

California

Research Site, La Jolla, California, 92093, United States
Reclutando

Massachusetts

Research Site, Boston, Massachusetts, 02215, United States
Retirado

New Jersey

Research Site, Hackensack, New Jersey, 07601, United States
Reclutando

New York

Research Site, New York, New York, 10021, United States
Reclutando
Research Site, New York, New York, 10029, United States
Reclutando

North Carolina

Research Site, Charlotte, North Carolina, 28203, United States
Reclutando
Research Site, Winston-Salem, North Carolina, 27157, United States
Reclutando

Texas

Research Site, Houston, Texas, 77030, United States
Reclutando

Washington

Research Site, Seattle, Washington, 98109, United States
Reclutando
Research Site, Melbourne, 3000, Australia
Reclutando
Research Site, Nedlands, 6009, Australia
Reclutando

Alberta

Research Site, Calgary, Alberta, T2N 5G2, Canada
Reclutando

Ontario

Research Site, Toronto, Ontario, M5G 2M9, Canada
Reclutando

Quebec

Research Site, Montreal, Quebec, H3T 1R2, Canada
Reclutando
Research Site, Hangzhou, 310003, China
Reclutando
Research Site, Shanghai, 200025, China
Reclutando
Research Site, København Ø, 2100, Denmark
Reclutando
Research Site, Pessac, 33604, France
Reclutando
Research Site, Villejuif, 94805, France
Reclutando
Research Site, München, 81675, Germany
Reclutando
Research Site, Ulm, 89081, Germany
Reclutando
Research Site, Würzburg, 97080, Germany
Reclutando
Research Site, Bologna, 40138, Italy
Reclutando
Research Site, Milan, 20133, Italy
Reclutando
Research Site, Chūōku, 104-0045, Japan
Reclutando
Research Site, Kashiwa, 277-8577, Japan
Reclutando