NCT04789655

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

A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid

Interventions

Type	Name	Description
DRUG	CC-96191	CC-96191

Timeline

• Start date: 2021-06-16
• Primary completion: 2025-04-14
• Completion: 2025-04-14
• First posted: 2021-03-09
• Last updated: 2025-05-31

Locations

14 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated drug study