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

Official Title

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


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.

Trial Description

Primary Outcome:

  • Dose limiting toxicities (DLTs)
  • Maximum tolerated dose (MTD)
  • Adverse Events (AEs)
Secondary Outcome:
  • Complete remission rate (CRR)
  • Objective response rate (ORR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vss
  • Presence of anti-drug antibodies (ADA)
  • Frequency of anti-drug antibodies (ADA)

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society