Calendario›ARTV›AB-101
AB-101
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus
Ensayo de Artiva Biotherapeutics, Inc. en Nefritis lupica - clase III de la OMS · Nefritis lupica - clase IV de la OMS · Lupus eritematoso sistemico refractario · LES.
- Fase
- Fase 1
- Estado
- En marcha, sin reclutar
- Participantes
- 51
- Centros
- 9
- Fin del objetivo primario
- ago 2027
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2024.
Qué mide
Incidencia de acontecimientos adversos surgidos del tratamiento y acontecimientos adversos graves (From the time of consent through 104 weeks after initiation of study treatment) (del registro, en inglés)
Qué se prueba
El objetivo es evaluar la seguridad, tolerabilidad y actividad preliminar de AB-101 junto con un anticuerpo que depleciona celulas B, tras ciclofosfamida y fludarabina, en adultos con nefritis lupica refractaria o recidivante de clase III o IV.
Lo que dice el documentoThe primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroAB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches, or other forms of refractory systemic lupus erythematosus. The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus a B-cell depleting mAb (e.g., rituximab, obinutuzumab) after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V, or other forms of refractory systemic lupus erythematosus. Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with a B-cell depleting mAb (e.g., rituximab, obinutuzumab). All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status. Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.
Más ensayos de ARTV
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Allogeneic NK Cells | Fase 2 | Reclutando pacientes | ene 2028 (prevista) |
| AB-201 | Fase 1/2 | Retirado antes de empezar | abr 2027 (prevista) |
| AB-101 | Fase 1/2 | Completado | oct 2025 (real) |
Todos los de ARTV, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06265220), actualizada en dic 2025.