Acute Myeloid Leukemia Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:

Bristol-Myers Squibb

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There are 36 Locations for this study

See Locations Near You

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
Los Angeles California, 90095, United States More Info
Steven Tsai, Site 0030
Contact
626-862-5788
Local Institution
Stanford California, 94305, United States More Info
Site 0031
Contact
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami Florida, 33136, United States More Info
Justin Watts, Site 0047
Contact
404-272-0609
Local Institution
Chicago Illinois, 60611, United States More Info
Site 0002
Contact
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
UT Southwestern-Harold C. Simmons Cancer Center
Dallas Texas, 75235, United States More Info
Yazan Madanat, Site 0051
Contact
214-648-7097
The University Of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Naval Daver, Site 0001
Contact
713-794-4392
Local Institution - 0027
Wollongong New South Wales, 2500, Australia More Info
Site 0027
Contact
Local Institution - 0006
Clayton Victoria, 3168, Australia More Info
Site 0006
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Local Institution
Heidelberg Victoria, 3084, Australia More Info
Site 0005
Contact
Local Institution - 0037
Melbourne Victoria, 3065, Australia More Info
Site 0037
Contact
Local Institution - 0019
Edmonton Alberta, T6G 2, Canada More Info
Site 0019
Contact
Local Institution - 0011
Vancouver British Columbia, V5Z 1, Canada More Info
Site 0011
Contact
Local Institution
Toronto Ontario, M5G 2, Canada More Info
Site 0010
Contact
Local Institution - 0038
Montreal Quebec, H3T 1, Canada More Info
Site 0038
Contact
Local Institution
Odense , 5000, Denmark
Local Institution - 0040
Marseille , 13273, France More Info
Site 0040
Contact
Local Institution - 0029
Nantes , 44000, France More Info
Site 0029
Contact
Local Institution - 0020
Pessac , 33600, France More Info
Site 0020
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Local Institution - 0023
Toulouse , 31059, France More Info
Site 0023
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Local Institution - 0041
Villejuif , 94805, France More Info
Site 0041
Contact
Local Institution
Meldola , 47014, Italy More Info
Site 0018
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Local Institution - 0026
Milan , 20162, Italy More Info
Site 0026
Contact
Local Institution
Rozzano , 20089, Italy More Info
Site 0017
Contact
Local Institution
Bergen , 5012, Norway More Info
Site 0025
Contact
Local Institution - 0013
Oslo , N-002, Norway More Info
Site 0013
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Local Institution - 0032
Badalona , 08916, Spain More Info
Site 0032
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Local Institution - 0039
Barcelona , 08041, Spain More Info
Site 0039
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Local Institution - 0036
Madrid , 28007, Spain More Info
Site 0036
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Local Institution - 0035
Salamanca , 37007, Spain More Info
Site 0035
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Local Institution - 0028
Santander , 39008, Spain More Info
Site 0028
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Local Institution - 0021
Gothenburg , 413 4, Sweden More Info
Site 0021
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Local Institution - 0015
Lund , 22185, Sweden More Info
Site 0015
Contact
Local Institution - 0014
Stockholm , 141 8, Sweden More Info
Site 0014
Contact
Local Institution - 0044
Edinburgh Midlothian, EH4 2, United Kingdom More Info
Site 0044
Contact
Local Institution - 0050
Oxford Oxfordshire, OX3 7, United Kingdom More Info
Site 0050
Contact
Local Institution
Oxford , OX3 7, United Kingdom More Info
Site 0048
Contact

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

30

Study ID:

NCT05168202

Recruitment Status:

Recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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