A Study of AZD0120 in Autoimmune Diseases

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 1 / Fase 2

Rango de edad

18 años - 75 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

27 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• Capable of giving signed informed consent.
• Adequate physiological function and reserve at screening.
• Able to comply with recommended medication washout period.
• Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.
• Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria.
• Particpant musy be 18-years-old to ≤ 75-years-old inclusive at the time of signing the informed consent
• Others as described in Clinical Study Protocol

Exclusion Criteria:

• Any prior CAR T exposure.
• Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 administration.
• Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.
• Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.
• Has certain cardiac conditions that could make it unsafe or unsuitable to take part in the study.
• Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.
• Uncontrolled hypertension (\> 160/100 mmHg) or symptomatic hypertension.
• Any central nervous system disease that may impact participants safety in the investigator's opinion.
• Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor.
• Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening
• History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.
• Known genetic inborn error of immunity and/or primary immunodeficiency.
• Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.
• Seropositive for HIV or HTLV.
• Active viral hepatitis are excluded.
• Active syphilis, positive for Treponema pallidum antibody.
• Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.
• Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals.
• Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.
• Contraindications or hypersensitivity to fludarabine and cyclophosphamide.
• \- Major surgery within 8 weeks prior to apheresis or has surgery planned during the study.
• Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
• Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).
• Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.
• Other protocol-defined eligibility criteria may apply.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Medidas secundarias

Centros de investigación (27)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

27 centros

Equipo y fechas

Patrocinador principal

AstraZeneca

Inicio del estudio

9 ene 2026 Real

Finalización primaria

22 feb 2028 Estimado

Finalización del estudio

22 feb 2028 Estimado

Primera publicación

22 dic 2025 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio