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

NCT04789655 | Terminated Phase 1 FDA Drug

• 3 other identifiers: CC-96191-AML-001U1111-1264-54122022-500573-13-00
• Study Type: interventional
• Target: 45
• Locations: 3 countries
• Sites: 14

Brief 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

Keywords

Acute Myeloid Leukemia; CC-96191; Relapsed or refractory

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicities (DLTs)

  Are defined as toxicities that meet the protocol-specified criteria occurring within the DLT assessment window (Cycle 1, Days 1 to at least 28 and up to 42 days) that cannot be attributed to a clearly identifiable cause such as underlying illness, disease progression, other concurrent illness, or concomitant medication.

  Up to 42 days after the first dose

• Maximum tolerated dose (MTD)

  Is defined as the highest dose at which less than 33% of the population treated with CC-96191 experience a dose limiting toxicity (DLT) in the first cycle.

  Up to 35 days after the last dose

• Adverse Events (AEs)

  Type, frequency, seriousness, severity and relationship of AEs to CC-96191

  Up to 35 days after the last dose

Secondary Outcomes (14)

• Complete remission rate (CRR)

  Up to approximately 2 years

• Objective response rate (ORR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

• Duration of remission

  Up to approximately 2 years

Study Arms (1)

CC-96191

EXPERIMENTAL

CC-96191 will be administered intravenously on a 28-day Cycle

Drug: CC-96191

Interventions

CC-96191 DRUG

CC-96191

CC-96191

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:.
• Participant must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
• Participant is ≥ 18 years of age at the time of signing the ICF.
• 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.
• Participant has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• At least 4 weeks (from first dose) has elapsed from donor lymphocyte infusion without conditioning.
• Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and during the safety follow-up period.

You may not qualify if:

• The presence of any of the following will exclude a Participant from enrollment:.
• Participant is suspected or proven to have acute promyelocytic leukemia (FAB M3) based on morphology, immunophenotype, molecular assay, or karyotype.
• Participant has received systemic anticancer therapy (including investigational therapy) or radiotherapy \< 28 days or 5 half-lives, whichever is shorter, prior to the start of study treatment. Hydroxyurea is allowed to control peripheral leukemia blasts.
• Participants with prior autologous hematopoietic stem cell transplant who, in the investigator's judgment, have not fully recovered from the effects of the last transplant (eg, transplant-related side effects).
• Prior allogeneic HSCT with either standard or reduced intensity conditioning ≤ 6 months prior to dosing.
• Participants on systemic immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of topical steroids for ongoing skin or ocular GVHD is permitted.
• Participant has persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to \< Grade 2.
• Participant has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.
• History of concurrent second cancers requiring active, ongoing systemic treatment.
• Participant is known seropositive or active infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus or hepatitis C virus.
• Impaired cardiac function or clinically significant cardiac diseases, as defined in the protocol.
• Participant is a pregnant or lactating female.
• Participant with isolated extramedullary disease without bone marrow involvement.
• Inadequate pulmonary function as defined as oxygen saturation (SpO2) \< 92% on room air.

Sponsors & Collaborators

• Celgene: lead

Study Sites (14)

Local Institution - 109

Birmingham, Alabama, 35233, United States

Location

Local Institution - 105

Jacksonville, Florida, 32224, United States

Location

Local Institution - 108

Atlanta, Georgia, 30322, United States

Location

Local Institution - 110

Rochester, Minnesota, 55905, United States

Location

Local Institution - 101

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 102

New York, New York, 10029, United States

Location

Local Institution - 107

Houston, Texas, 77030-4009, United States

Location

Local Institution - 111

Seattle, Washington, 98104, United States

Location

Local Institution - 202

Calgary, Alberta, T2N 5G2, Canada

Location

Local Institution - 201

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 303

Marseille, 13273, France

Location

Local Institution - 304

Paris, 75010, France

Location

Local Institution - 301

Pessac, 33604, France

Location

Local Institution - 302

Villejuif, 94805, France

Location

Related Publications (1)

• Lunn-Halbert MC, Laszlo GS, Erraiss S, Orr MT, Jessup HK, Thomas HJ, Chan H, Jahromi MA, Lloyd J, Cheung AF, Chang GP, Dichwalkar T, Fallon D, Grinberg A, Rodriguez-Arboli E, Lim SYT, Kehret AR, Huo J, Cole FM, Scharffenberger SC, Walter RB. Preclinical Characterization of the Anti-Leukemia Activity of the CD33/CD16a/NKG2D Immune-Modulating TriNKET(R) CC-96191. Cancers (Basel). 2024 Feb 22;16(5):877. doi: 10.3390/cancers16050877.

  PMID: 38473239 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Leukemia, Myeloid; Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 9, 2021
• Study Start: June 16, 2021
• Primary Completion: April 14, 2025
• Study Completion: April 14, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CA (2); US (8); FR (4)