Trial Outcomes & Findings for BMS-986253 in Myelodysplastic Syndromes (NCT NCT05148234)
NCT ID: NCT05148234
Last Updated: 2025-09-30
Results Overview
OBD of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). DLT is defined as any of the following: any grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal. OBD is the lowest tolerated dose level showing optimal biological activity, defined as maximal suppression of serum free IL-8 levels. The goal is to achieve IL-8 levels below the lower limit of detection of the assay in real time by Ultrasensitive immunoassay based on Quanterix Simoa technology. The lower limit of quantification = 0.86 pg/mL by Myriad-Rules Based Medicine (RBM).
TERMINATED
PHASE1/PHASE2
2 participants
First 28 days (C1D28) on up to 30 days.
2025-09-30
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level -1: 600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 2: 2400 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 3: 3600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants
Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase I
STARTED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase I
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase II
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Dose Level -1: 600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 2: 2400 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Dose Level 3: 3600 mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Phase I Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Phase II Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Phase II Lower Risk (LR) Myelodysplastic Syndromes (MDS) Participants
Phase II dose of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) for lower risk (LR) myelodysplastic syndromes (MDS) participants.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration (FDA) product label.
|
Enrolled But Not Treated
Participant was enrolled but not treated.
|
|---|---|---|---|---|---|---|---|---|
|
Phase I
Ineligible
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Phase I
Company closed the trial.
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
BMS-986253 in Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
n=1 Participants
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
Enrolled But Not Treated
n=1 Participants
Participant was enrolled but not treated.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 0 • n=5 Participants
|
44 years
STANDARD_DEVIATION 0 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 13.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 28 days (C1D28) on up to 30 days.Population: 1/2 participants were enrolled but not treated.
OBD of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). DLT is defined as any of the following: any grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal. OBD is the lowest tolerated dose level showing optimal biological activity, defined as maximal suppression of serum free IL-8 levels. The goal is to achieve IL-8 levels below the lower limit of detection of the assay in real time by Ultrasensitive immunoassay based on Quanterix Simoa technology. The lower limit of quantification = 0.86 pg/mL by Myriad-Rules Based Medicine (RBM).
Outcome measures
| Measure |
All Participants
n=1 Participants
Phase I Dose Level 1: All participants who received at least on dose of drug.
|
|---|---|
|
Phase I: Optimal Biological Dose (OBD) for Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)
With DNMTi
|
NA mg
The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the maximum tolerated doses. There is not enough data to determine OBD.
|
|
Phase I: Optimal Biological Dose (OBD) for Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)
Without DNMTi
|
NA mg
The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the maximum tolerated doses. There is not enough data to determine OBD.
|
PRIMARY outcome
Timeframe: First 28 days (C1D28)Population: 1/2 participants were enrolled but not treated.
RP2D of BMS-986253 with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi), as determined by dose -limiting toxicity (DLT) occurring by cycle 1 day 28 (C1D28). RP2D is defined as the optimal biological dose expected to be safe and of potential efficacy. It serves as a starting point for further investigations in future phase 2 clinical trials. DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal.
Outcome measures
| Measure |
All Participants
n=1 Participants
Phase I Dose Level 1: All participants who received at least on dose of drug.
|
|---|---|
|
Phase I: Recommended Phase 2 Dose (RP2D) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)
With DNMTi
|
NA mg
The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the Recommended Phase 2 Dose (RP2D). There is not enough data to determine MTD.
|
|
Phase I: Recommended Phase 2 Dose (RP2D) of Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253)
Without DNMTi
|
NA mg
The DLT (dose limiting toxicity) refers to the highest dose of a drug that causes unacceptable or intolerable side effects or toxicities. Once we identify DLTs, we can identify the Recommended Phase 2 Dose (RP2D). There is not enough data to determine MTD.
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome measure was not done because the company closed the study prior to phase II.
Overall response rate (ORR= Complete Remission (CR) + Partial Remission (PR) + \[marrow CR + hematologic improvement (HI\]) of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) with and without deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) after 6 cycles of therapy was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \>5%. And cellularity and morphology not relevant.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: First 28 days and follow up after the end of the treatment cycle; approximately 2 months.Population: 1/2 participants were enrolled but not treated.
Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
All Participants
n=1 Participants
Phase I Dose Level 1: All participants who received at least on dose of drug.
|
|---|---|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grades 1-5 Serious related to BMS-986253
|
0 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grades 1-5 Non-serious related to BMS-986253
|
0 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grade 1 -2 Serious related to DNMTi
|
0 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grade 3 Serious related to DNMTi - Febrile neutropenia
|
1 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grade 3 Serious related to DNMTi - Skin infection
|
1 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grade 2 Non-serious related to DNMTi - Lymphocyte count decreased
|
1 adverse events
|
|
Phase I: Number of Grades 1-5 Serious and/or Non-serious Adverse Events Related to Human Humax (HuMax)-Interleukin 8 (IL-8) (BMS-986253) and Deoxyribonucleic Acid (DNA) Methyltransferase Inhibitors (DNMTi)
Grade 3 Non-serious related to DNMTi - White blood cell decreased
|
1 adverse events
|
PRIMARY outcome
Timeframe: Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cyclesPopulation: This outcome measure was not done because the company closed the study prior to phase II.
Clinical response was assessed by the assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes and reported with 95% confidence interval. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \>5%. And cellularity and morphology not relevant. Stable disease is failure to achieve at least PR, but no evidence of progression for \>8 weeks. Progression is less than 5% blasts: ≥50% increase in blasts to \>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; transfusion dependence. Relapse after CR or PR is at least 1 of the following: return to pre-treatment bone marrow blast percentage or decrement of ≥50% from maximum remission/response levels in granulocytes or platelets.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.Population: Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.
AUC is a measure of the serum concentration of drug BMS-986253 over time. It is used to characterize drug absorption.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.Population: Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Before infusion, within 30 minutes, start of infusion, 1, 4, 12, and 24 hours after end of infusion.Population: Samples were stored but data were not analyzed because the manufacturer responsible for analyzing the samples terminated the study. No future data analysis will be conducted for samples stored for this terminated study.
Concentration of BMS-986253 at steady state in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: This outcome measure was not done because the company closed the study prior to phase II.
Safety as measured by incidence of adverse events (AEs) and serious adverse events (SAEs), and AEs leading to discontinuation, death, and laboratory abnormalities. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 if life-threatening. Grade 5 is death related to adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study treatment until occurrence of disease progression, death, or unacceptable toxicity or until response assessment on Cycle 7 day 1 (C7D1), a maximum of 6 cyclesPopulation: This outcome measure was not done because the company closed the study prior to phase II.
Cytogenetic Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Cytogenetic complete response is disappearance of the chromosomal abnormality without appearance of new ones. Cytogenetic partial response is at least 50% reduction of the chromosomal abnormality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time to best responsePopulation: This outcome measure was not done because the company closed the study prior to phase II.
Time to best response (Complete Remission (CR), Partial Remission (PR), marrow CR + HI, HI) using the Kaplan-Meier method. Response was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Partial Remission (PR) is all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pretreatment but still \>5%. And cellularity and morphology not relevant. Hematologic improvement (HI) is defined as: Erythroid response - at least 2 consecutive hemoglobin (hgb) measurements \>1.5 g/dL for a period of minimum 8 weeks in an observation period of 16-24 weeks compared with the lowest mean of 2 hgb measurements within 16 weeks before treatment onset. Platelet response - absolute increase of 30x10\^9/L for participants starting with \>20x10\^9/L platelets.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study closurePopulation: This outcome measure was not done because the company closed the study prior to phase II.
DFS is defined as time to relapse for participants who achieve complete remission (CR) using the Kaplan-Meier method. Complete Remission (CR) is bone marrow ≤55% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study closurePopulation: This outcome measure was not done because the company closed the study prior to phase II.
PFS is defined as disease progression or death from Myelodysplastic Syndromes (MDS). Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \>20% blasts; 20%-30% blasts: ≥50% increase to \>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study closurePopulation: This outcome measure was not done because the company closed the study prior to phase II.
LFS is defined as progression to acute myeloid leukemia (AML) or death from any cause using the Kaplan-Meier method. Progression was assessed by the 2006 International Working Group response criteria for Myelodysplastic Syndromes using the Kaplan-Meier method and is defined as less than 5% blasts: ≥50% increase in blasts to \>5% blasts; 5%-10% blasts: ≥50% increase to 10% blasts; 10%-20% blasts: ≥50% increase to \>20% blasts; 20%-30% blasts: ≥50% increase to \>30% blasts and any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets, reduction in Hgb by ≥2 g/dL, and transfusion dependence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Until study closurePopulation: This outcome measure was not done because the company closed the study prior to phase II.
OS is defined as death from any cause using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From first study intervention, study day 1, through study day 100 after the end of the treatment cycle; approximately 7 months.Population: 1/2 participants were enrolled but not treated.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants
n=1 Participants
Phase I Dose Level 1: All participants who received at least on dose of drug.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First 28 daysPopulation: 1/2 participants were enrolled but not treated.
DLT is defined as any of the following: ang grade ≥ non-hematologic toxicity that is possibly, probably, or definitely related to study drug. Liver injury as defined by a positive Hy's Law. And adverse reaction that leads to dose reduction or withdrawal.
Outcome measures
| Measure |
All Participants
n=1 Participants
Phase I Dose Level 1: All participants who received at least on dose of drug.
|
|---|---|
|
Phase I: Proportion of Participants With Dose-limiting Toxicities (DLT)
|
0 proportion of participants
|
Adverse Events
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
Serious adverse events
| Measure |
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
n=1 participants at risk
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
|
Infections and infestations
Skin infection
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
Other adverse events
| Measure |
Phase I Dose Level 1: 1200mg Eligible Higher Risk (HR) Myelodysplastic Syndromes (MDS) Participants
n=1 participants at risk
Escalating doses of Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) + deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) for higher risk (HR) myelodysplastic syndromes (MDS) participants.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine: For Higher Risk (HR) Myelodysplastic Syndromes (MDS) cohort, the study drug of BMS-986253 will be given in combination with standard of care (SOC) Food and Drug Administration (FDA)-approved DNMTi by mouth (PO) decitabine and cedazuridine according to guidelines outlined in FDA product label. Standard of care (SOC) DNMTi will be administered via oral route once daily starting Day (D)2 of each treatment cycle through D6.
BMS-986253: Intravenous (IV) infusion, 200 mg/Vial (20 mg/mL) or 1000 mg/vial (100mg/mL). Abbreviated Title: Human Humax (HuMax)-interleukin 8 (IL-8) (BMS-986253) in Myelodysplastic Syndromes 34 Version Date: 9/08/2021 outlined in Food and Drug Administration product label.
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
|
Investigations
White blood cell decreased
|
100.0%
1/1 • Number of events 1 • From first study intervention, study day 1, through study day 100 after after the end of the treatment cycle; approximately 7 months.
1/2 participants were enrolled but not treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place