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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05168202
Recruitment Status : Recruiting
First Posted : December 23, 2021
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 Intervention/treatment Phase
Leukemia, Myeloid, Acute Myelodysplastic Syndromes Drug: CC-95251 Drug: Azacitidine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Actual Study Start Date : January 19, 2022
Estimated Primary Completion Date : June 14, 2026
Estimated Study Completion Date : June 14, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Azacitidine

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

Drug: Azacitidine
Specified dose on specified days


Outcome Measures
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05168202


Contacts
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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
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05168202    
Other Study ID Numbers: CA059-001
2021-002799-38 ( EudraCT Number )
First Posted: December 23, 2021    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023

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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:
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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
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors