drugset / Trial / NCT04789655

Study of CC-96191 in Participants With Relapsed or Refractory Acute Myeloid Leukemia

NCT04789655 ↗

Phase 1 Terminated 45 enrolled Celgene Corporation
NaSingle-groupOpen-labelTreatment

Summary

This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML). The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy. The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

Timeline

Start
2021-06-16
Primary completion
2025-04-14
Completion
2025-04-14

Outcome

Outcome not reported

Stopped (Business): “Business objectives have changed”

Drugs

EvaluationDrugModalityDoseRoute
Subject CC-96191 Other / unclassified — Intravenous

Indications