18 and older, any sex, with Leukemia, Myeloid, Acute or Myelodysplastic Syndromes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With DLTsPrimary· From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days)
A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include:
* Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash).
* Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \>2× ULN without cholestasis).
* Hematologic toxicities: Grade 4 neutropenia/thrombocytopenia persisting at Day 28 without active AML/MDS; febrile neutropenia or
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
1
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
2
Part A: Treatment 7
4
Number of Participants With Treatment Emergent Adverse EventsPrimary· From signing informed consent to 56 days post last dose (Approximately 30 months)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Group
Value
95% CI
Part A: Treatment 1
6
Part A: Treatment 2
8
Part A: Treatment 3
8
Part A: Treatment 4
9
Part A: Treatment 5
8
Part A: Treatment 6
10
Part A: Treatment 7
5
Number of Participants With With Grade 3 or Higher Laboratory AbnormalitiesPrimary· From signing informed consent to 56 days post last dose (Approximately 30 months)
Clinical laboratory values from laboratories will be graded according to CTCAE Version 5 for applicable tests programmatically. For laboratory values that fall outside of the grade criteria of CTCAE Version 5, a Grade of 0 will be assigned. In addition, normal ranges will be used to determine the categories of High, Low, and Normal for laboratory tests that have no severity grade.
hemoglobin
Group
Value
95% CI
Part A: Treatment 1
4
Part A: Treatment 2
6
Part A: Treatment 3
7
Part A: Treatment 4
8
Part A: Treatment 5
7
Part A: Treatment 6
10
Part A: Treatment 7
5
platelet count
Group
Value
95% CI
Part A: Treatment 1
5
Part A: Treatment 2
8
Part A: Treatment 3
9
Part A: Treatment 4
10
Part A: Treatment 5
8
Part A: Treatment 6
10
Part A: Treatment 7
5
leukocytes
Group
Value
95% CI
Part A: Treatment 1
5
Part A: Treatment 2
5
Part A: Treatment 3
6
Part A: Treatment 4
9
Part A: Treatment 5
7
Part A: Treatment 6
9
Part A: Treatment 7
4
lymphocytes
Group
Value
95% CI
Part A: Treatment 1
4
Part A: Treatment 2
5
Part A: Treatment 3
4
Part A: Treatment 4
7
Part A: Treatment 5
7
Part A: Treatment 6
9
Part A: Treatment 7
2
neutrophils
Group
Value
95% CI
Part A: Treatment 1
3
Part A: Treatment 2
6
Part A: Treatment 3
8
Part A: Treatment 4
8
Part A: Treatment 5
8
Part A: Treatment 6
8
Part A: Treatment 7
4
Alanine aminotransferase
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
1
Part A: Treatment 3
1
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
3
Part A: Treatment 7
1
alkaline phosphatase
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
1
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
0
Part A: Treatment 7
1
asparatate aminotransferase
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
1
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
1
Part A: Treatment 7
1
Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse EventsPrimary· From screening to 56 days post last dose (Approximately 29 months)
A single ECG will be performed in Screening, Cycle 1 Day 1 and 15, and Day 1 of Cycles ≥ 2. Investigators will make immediate clinical decisions based on their interpretation of the ECG results and provide their overall assessment.
Sinus Tachycardia
Group
Value
95% CI
Part A: Treatment 1
1
Part A: Treatment 2
0
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
2
Part A: Treatment 7
0
Tachycardia
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
0
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
0
Part A: Treatment 6
2
Part A: Treatment 7
0
Atrial Fibrillation
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
1
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
1
Part A: Treatment 6
0
Part A: Treatment 7
0
Sinus Bradycardia
Group
Value
95% CI
Part A: Treatment 1
0
Part A: Treatment 2
0
Part A: Treatment 3
0
Part A: Treatment 4
0
Part A: Treatment 5
1
Part A: Treatment 6
0
Part A: Treatment 7
0
Number of ECOG Evaluations With Shift of ECOG Score of 3 or Greater.Primary· From screening to 56 days post last dose (Approximately 29 months)
ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without estriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or b
Group
Value
95% CI
Part A: Treatment 1
3
Part A: Treatment 2
1
Part A: Treatment 3
0
Part A: Treatment 4
1
Part A: Treatment 5
0
Part A: Treatment 6
1
Part A: Treatment 7
1
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEsPrimary· From signing informed consent to 56 days post last dose (Approximately 30 months)
AUC(0-T)Secondary· On Cycle 1 Day 1, C1D22 and C2D22.
Area under the plasma concentration time-curve up to the last measurable concentration (AUC0-t)
Cycle 1 Day 1
Group
Value
95% CI
Part A: Treatment 1
27915.38
± 25.74
Part A: Treatment 2
37242.17
± 41.18
Part A: Treatment 3
13125.85
± 48.00
Part A: Treatment 4
23850.09
± 50.97
Part A: Treatment 5
49377.47
± 10.90
Part A: Treatment 6
28557.98
± 61.21
Part A: Treatment 7
42273.81
± 28.09
Cycle 1 Day 22
Group
Value
95% CI
Part A: Treatment 1
25766.21
± 366.57
Part A: Treatment 2
53952.86
± 105.79
Part A: Treatment 3
38363.45
± 34.52
Part A: Treatment 4
46250.05
± 55.29
Part A: Treatment 5
84673.85
± 80.82
Part A: Treatment 6
63857.81
± 83.67
Part A: Treatment 7
186843.83
± 120.44
Cycle 2 Day 22
Group
Value
95% CI
Part A: Treatment 1
42891.42
± 38.09
Part A: Treatment 2
54797.36
± 205.65
Part A: Treatment 3
37672.97
± 30.69
Part A: Treatment 4
54425.19
± 131.05
Part A: Treatment 5
116229.58
± 23.27
Part A: Treatment 6
74865.57
± 104.46
Part A: Treatment 7
137581.5
± NA
AUC(TAU)Secondary· On Cycle 1 Day 1, C1D22 and C2D22.
Area under the plasma concentration time-curve during a dosing interval (AUCtau)
Cycle 1 Day 1
Group
Value
95% CI
Part A: Treatment 1
27915.38
± 25.74
Part A: Treatment 2
39145.67
± 33.39
Part A: Treatment 3
15987.61
± 16.16
Part A: Treatment 4
28817.51
± 27.62
Part A: Treatment 5
49377.47
± 10.90
Part A: Treatment 6
29931.17
± 64.80
Part A: Treatment 7
46778.93
± 18.30
Cycle 1 Day 22
Group
Value
95% CI
Part A: Treatment 1
48306.42
± 48.94
Part A: Treatment 2
87419.67
± 68.23
Part A: Treatment 3
34295.76
± 16.51
Part A: Treatment 4
64776.31
± 16.33
Part A: Treatment 5
120818.65
± 32.18
Part A: Treatment 6
57119.56
± 67.28
Part A: Treatment 7
109428.93
± 41.91
Cycle 2 Day 22
Group
Value
95% CI
Part A: Treatment 1
48436.92
± 44.72
Part A: Treatment 2
128864.45
± 8.24
Part A: Treatment 3
37672.97
± 30.69
Part A: Treatment 4
89459.57
± 19.99
Part A: Treatment 5
119737.08
± 25.79
Part A: Treatment 6
114221.87
± 19.11
Part A: Treatment 7
137581.85
± NA
CminSecondary· On Cycle 1 Day 1, C1D22 and C2D22.
Minimum serum concentration
Cycle 1 Day 1
Group
Value
95% CI
Part A: Treatment 1
NA
± NA
Part A: Treatment 2
1.96
± NA
Part A: Treatment 3
NA
± NA
Part A: Treatment 4
140.00
± NA
Part A: Treatment 5
NA
± NA
Part A: Treatment 6
NA
± NA
Part A: Treatment 7
0.47
± NA
Cycle 1 Day 22
Group
Value
95% CI
Part A: Treatment 1
149.97
± 50.58
Part A: Treatment 2
213.59
± 104.90
Part A: Treatment 3
109.90
± 40.52
Part A: Treatment 4
153.17
± 97.33
Part A: Treatment 5
342.42
± 39.35
Part A: Treatment 6
167.12
± 89.50
Part A: Treatment 7
336.79
± 54.07
Cycle 2 Day 22
Group
Value
95% CI
Part A: Treatment 1
171.28
± 48.96
Part A: Treatment 2
588.04
± 36.19
Part A: Treatment 3
135.10
± 44.61
Part A: Treatment 4
225.45
± 37.09
Part A: Treatment 5
573.75
± 46.78
Part A: Treatment 6
291.15
± 94.88
Part A: Treatment 7
545.00
± NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part A: Treatment 1
Serious: 6/6 (100%)
Deaths: 6/6
Part A: Treatment 2
Serious: 7/8 (88%)
Deaths: 7/8
Part A: Treatment 3
Serious: 8/9 (89%)
Deaths: 6/9
Part A: Treatment 4
Serious: 7/10 (70%)
Deaths: 9/10
Part A: Treatment 5
Serious: 7/8 (88%)
Deaths: 6/8
Part A: Treatment 6
Serious: 10/10 (100%)
Deaths: 8/10
Part A: Treatment 7
Serious: 5/5 (100%)
Deaths: 3/5
Serious adverse events (68 terms)
Reaction
System
Part A: Treatment 1
Part A: Treatment 2
Part A: Treatment 3
Part A: Treatment 4
Part A: Treatment 5
Part A: Treatment 6
Part A: Treatment 7
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
—
—
—
—
Disease progression
General disorders
—
—
—
—
—
—
—
Pyrexia
General disorders
—
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
—
Septic shock
Infections and infestations
—
—
—
—
—
—
—
Disseminated intravascular coagulation
Blood and lymphatic system disorders
—
—
—
—
—
—
—
Thrombocytopenia
Blood and lymphatic system disorders
—
—
—
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
—
—
—
Ileus paralytic
Gastrointestinal disorders
—
—
—
—
—
—
—
General physical health deterioration
General disorders
—
—
—
—
—
—
—
Generalised oedema
General disorders
—
—
—
—
—
—
—
Multiple organ dysfunction syndrome
General disorders
—
—
—
—
—
—
—
Haemophagocytic lymphohistiocytosis
Immune system disorders
—
—
—
—
—
—
—
Anal abscess
Infections and infestations
—
—
—
—
—
—
—
COVID-19
Infections and infestations
—
—
—
—
—
—
—
COVID-19 pneumonia
Infections and infestations
—
—
—
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
—
—
—
Clostridium difficile colitis
Infections and infestations
—
—
—
—
—
—
—
Clostridium difficile infection
Infections and infestations
—
—
—
—
—
—
—
Device related infection
Infections and infestations
—
—
—
—
—
—
—
Diverticulitis
Infections and infestations
—
—
—
—
—
—
—
Escherichia sepsis
Infections and infestations
—
—
—
—
—
—
—
Fungal infection
Infections and infestations
—
—
—
—
—
—
—
Other adverse events (193 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03783403 — A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic C
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 25 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05168202.