Calendario›ARTV›AB-101

AB-101

AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Ensayo de Artiva Biotherapeutics, Inc. en Linfoma no Hodgkin.

Más ensayos de: Linfoma no Hodgkin.

Fase

Fase 1/2

Estado

Completado

Participantes

45

previstos

Centros

21

Fin del objetivo primario

oct 2025

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en mar 2021.

Qué mide

Fase 1: Seguridad y tolerabilidad de AB-101 en monoterapia, y en combinacion con rituximab (incluida la cohorte especifica de DLBCL) y en combinacion con bendamustina y rituximab. (From the ICF signature through 13 weeks after last study drug dose.) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAB-101 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 are known to kill cancer cells. This clinical trial will enroll patients with relapsed/refractory non-Hodgkin lymphoma of B-cell origin and is conducted in two phases. The primary objectives of Phase 1 are as follows: 1) to evaluate the safety of AB-101 given alone or in combination with rituximab (including the DLBCL specific cohort) or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and rituximab (combination cohorts only); and 3) to identify the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to determine whether AB-101 in combination with rituximab or in combination with bendamustine and rituximab has anti-cancer activity in patients. Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab (including DLBCL specific cohort) or in combination with bendamustine and rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and tumor response. Patients receiving AB-101 in combination with rituximab may receive up to 3 additional cycles of treatment. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 cycles of treatment.

Más ensayos de ARTV

Todos los de ARTV, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04673617), actualizada en mar 2026.