CytoAgents:CTO1681 (Diffuse Large B-Cell Lymphoma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental drug called CT01681 (the study drug) is a safe and effective option for people who get CAR T-cell therapy as a treatment for diffuse large B cell lymphoma (DLBCL). We want to know if the study drug has the potential to lower or prevent certain side effects of CAR T-cell therapy. The possible side effects of CAR T-cell therapy that the study drug is being developed to protect against are called cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome. This study is enrolling people who will receive an available form of CAR T-cell therapy called YESCARTA.

What is the Condition Being Studied?

Linfoma difuso de células B grandes (DLBCL)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with DLBCL
  • Are planning to receive YESCARTA CAR T-cell therapy

For more information about who can join this study, please contact the study team at caitlyn.campbell@duke.edu.

Grupo etario
Adultos

What is Involved?

Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos:

  • Un grupo recibirá el medicamento del estudio.
  • El otro grupo recibirá un placebo (sustancia inactiva que no contiene fármaco alguno))

Comenzará a tomar el fármaco del estudio el día anterior a la infusión de YESCARTA. Continuará tomando el fármaco del estudio durante 2 semanas después de la infusión (un total de 15 días). El fármaco del estudio es una pastilla que se toma 3 veces al día.

Study Details

Full Title
Un estudio de fase 1b/2a de CTO1681 para la prevención y tratamiento del síndrome de liberación de citocinas en pacientes con linfoma difuso de células B grandes que reciben terapia con células car t.
Principal Investigator
Especialista en oncología hematológica
Protocol Number
IRB: PRO00114755
NCT: NCT05905328
Phase
Phase I/II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción