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

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04789655
Protocol IDs
CC-96191-AML-001 (primary)
NCI-2021-02783
U1111-1264-5412
Study Sponsor
Celgene

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.

Eligibility

  1. Participants must satisfy the following criteria to be enrolled in the study:.
  2. Participant must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
  3. Participant is = 18 years of age at the time of signing the ICF.
  4. Relapsed or refractory CD33 positive AML at last visit as defined by the World Health Organization (WHO) Classification who have failed or who are ineligible for or have refused all available therapies for AML which may provide clinical benefit.
  5. Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  6. At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning.
  7. Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.