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A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

  • Clinicaltrials.gov identifier

    NCT05168202

  • Recruitment Status

    Recruiting

  • First Posted

    December 23, 2021

  • Last update posted

    March 14, 2022

Study Description

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical activity of CC-95251 alone and in combination with antineoplastic agents in participants with relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive higher risk melodysplastic syndromes.

  • Condition or Disease:Leukemia, Myeloid, Acute
    Myelodysplastic Syndromes
  • Intervention/Treatment: Drug: CC-95251
    Drug: Azacitidine
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
  • Actual Study Start Date: January 2022
  • Estimated Primary Completion Date: June 2026
  • Estimated Study Completion Date: June 2026

Arms and interventions

Arm Intervention/treatment
Experimental: CC-95251 + azacitidine
Drug: CC-95251
Specified dose on specified days

Drug: Azacitidine
Specified dose on specified days
Experimental: CC-95251 monotherapy
Drug: CC-95251
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Number of participants with a Dose-limiting toxicity (DLT) [ Time Frame: Up to 42 days ]
  • 2. Incidence of adverse events (AEs) [ Time Frame: Up to 56 days after the last dose of study treatment ]
  • Secondary Outcome Measures: 1. Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria [ Time Frame: Up to 2 years after end of treatment ]
  • 2. Overall response rate (ORR) for AML [ Time Frame: Up to 2 years after end of treatment ]
  • 3. CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria [ Time Frame: Up to 2 years after end of treatment ]
  • 4. ORR for MDS [ Time Frame: Up to 2 years after end of treatment ]
  • 5. Duration of remission [ Time Frame: Up to 2 years after end of treatment ]
  • 6. Duration of response [ Time Frame: Up to 2 years after end of treatment ]
  • 7. Stable disease rate is the rate of MDS participants whose best response is stable disease [ Time Frame: Up to 2 years after end of treatment ]
  • 8. Relapse-free survival [ Time Frame: Up to 2 years after end of treatment ]
  • 9. Event-free survival [ Time Frame: Up to 2 years after end of treatment ]
  • 10. Progression-free survival [ Time Frame: Up to 2 years after end of treatment ]
  • 11. Time to remission/response [ Time Frame: Up to 2 years after end of treatment ]
  • 12. Transfusion independence [ Time Frame: Up to 2 years after end of treatment ]
  • 13. Time to AML transformation for MDS participants [ Time Frame: Up to 2 years after end of treatment ]
  • 14. Overall survival (OS) rates at 6 months [ Time Frame: Up to 2 years after end of treatment ]
  • 15. OS rates at 12 months [ Time Frame: Up to 2 years after end of treatment ]
  • 16. Maximum plasma concentration of drug (Cmax) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
  • 17. Minimum serum concentration (Cmin) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
  • 18. Trough observed serum concentration (Ctrough) [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
  • 19. Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]
  • 20. Frequency of ADAs using a validated ECL assay [ Time Frame: Up to 8 weeks post-dose of CC-95251 ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria: • Eastern Cooperative Oncology Group Performance Status of 0 to 2 For Parts A & B: Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO Classification R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with intermediate, high or very high risk by Revised International Prognostic Scoring System (IPSS-R) For Part C: • Treatment-naïve (ie, previously untreated) MDS as defined by the 2016 WHO Classification with intermediate, high or very high risk by IPSS-R Exclusion Criteria: Acute promyelocytic leukemia Immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation Participants who have received prior treatment with a CD47 or SIRPα targeting agent Participant is on chronic systemic immunosuppressive therapy or corticosteroids Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or refractory participants only). Any condition including, active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study Pregnant or nursing participants. Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com

Contact: First line of the email MUST contain the NCT# and Site #.

Locations

United States, California
Local Institution
Marina Del Rey

United States, California
Local Institution
Stanford

United States, Florida
Local Institution
Miami

United States, Illinois
Local Institution
Chicago

United States, New York
Local Institution
Buffalo

United States, Texas
Local Institution
Houston

United States, Washington
Local Institution
Seattle

Australia, New South Wales
Local Institution
Wollongong

Australia, Victoria
Local Institution
Clayton

Australia, Victoria
Local Institution
Fitzroy

Australia, Victoria
Local Institution
Heidelberg

Canada, Alberta
Local Institution
Edmonton

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Montreal

Denmark
Local Institution
Odense

France
Local Institution
Marseille

France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology
Nantes

France
Local Institution
Pessac

France
Institut Claudius Regaud
Toulouse

France
Local Institution
Villejuif

Italy
Local Institution
Meldola

Italy
Local Institution
Milan

Italy
Local Institution
Rozzano

Norway
Local Institution
Bergen

Norway
Local Institution
Oslo

Spain
Local Institution
Badalona

Spain
Local Institution
Barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Salamanca

Spain
Local Institution
Santander

Sweden
Local Institution
Goteborg

Sweden
Local Institution
Huddinge

Sweden
Local Institution
Lund

United Kingdom
Local Institution
Edinburgh

United Kingdom
Local Institution
Oxford

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05168202 History of Changes
  • Other Study ID Numbers: CA059-001, 2021-002799-38
  • First Posted: December 23, 2021 Key Record Dates
  • Last Update Posted: March 14, 2022
  • Last Verified: March 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Myelodysplastic Syndromes
    Acute Myeloid Leukemia
    AML
    MDS
    Hematologic Cancers
    Leukemia
    Anti-SIRPa antibody
    CC-95251
  • Additional relevant MeSH terms: Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Preleukemia
    Myelodysplastic Syndromes
    Syndrome
    Disease
    Pathologic Processes
    Neoplasms by Histologic Type
    Neoplasms
    Bone Marrow Diseases
    Hematologic Diseases
    Precancerous Conditions