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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 14, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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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


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


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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United States, California
Local Institution Not yet recruiting
Marina Del Rey, California, United States, 90292
Contact: Site 0030         
Local Institution Not yet recruiting
Stanford, California, United States, 94305
Contact: Site 0031         
United States, Florida
Local Institution Not yet recruiting
Miami, Florida, United States, 33136
Contact: Site 0047         
United States, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 0002         
United States, New York
Local Institution Not yet recruiting
Buffalo, New York, United States, 14263
Contact: Site 0033         
United States, Texas
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0001         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Site 0046         
Australia, New South Wales
Local Institution Not yet recruiting
Wollongong, New South Wales, Australia, 2500
Contact: Site 0027         
Australia, Victoria
Local Institution Not yet recruiting
Clayton, Victoria, Australia, 3168
Contact: Site 0006         
Local Institution Not yet recruiting
Fitzroy, Victoria, Australia, 3065
Contact: Site 0037         
Local Institution Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0005         
Canada, Alberta
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Site 0019         
Canada, British Columbia
Local Institution Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1L9
Contact: Site 0011         
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0010         
Canada, Quebec
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H3t1e2
Contact: Site 0038         
Denmark
Local Institution Withdrawn
Odense, Denmark, 5000
France
Local Institution Not yet recruiting
Marseille, France, 13273
Contact: Site 0040         
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology Recruiting
Nantes, France, 44093
Contact: Pierre Peterlin, Site 0029    +33240083271      
Local Institution Not yet recruiting
Pessac, France, 33604
Contact: Site 0020         
Institut Claudius Regaud Recruiting
Toulouse, France, 31100
Contact: Christian Recher, Site 0023    +33531156355      
Local Institution Not yet recruiting
Villejuif, France, 94805
Contact: Site 0041         
Italy
Local Institution Not yet recruiting
Meldola, Italy, 47014
Contact: Site 0018         
Local Institution Not yet recruiting
Milan, Italy, 20162
Contact: Site 0026         
Local Institution Not yet recruiting
Rozzano, Italy, 20089
Contact: Site 0017         
Norway
Local Institution Not yet recruiting
Bergen, Norway, 5012
Contact: Site 0025         
Local Institution Not yet recruiting
Oslo, Norway, 0424
Contact: Site 0013         
Spain
Local Institution Not yet recruiting
Badalona, Spain, 08916
Contact: Site 0032         
Local Institution Not yet recruiting
Barcelona, Spain, 08049
Contact: Site 0039         
Local Institution Recruiting
Madrid, Spain, 28007
Contact: Site 0036         
Local Institution Recruiting
Salamanca, Spain, 37007
Contact: Site 0035         
Local Institution Recruiting
Santander, Spain, 39008
Contact: Site 0028         
Sweden
Local Institution Not yet recruiting
Goteborg, Sweden, 41345
Contact: Site 0021         
Local Institution Not yet recruiting
Huddinge, Sweden, 141 86
Contact: Site 0014         
Local Institution Not yet recruiting
Lund, Sweden, 222 42
Contact: Site 0015         
United Kingdom
Local Institution Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Site 0044         
Local Institution Not yet recruiting
Oxford, United Kingdom, OX3 7LE
Contact: Site 0048         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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 14, 2022
Last Verified: March 2022

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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