Study: NCT05148234

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Decitabine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deoxyribonucleic acid (DNA) methyltransferase inhibitors (DNMTi) Cedazuridine
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-986253
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-986253
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-986253
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: BMS-986253
Description: 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.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Bone marrow biopsy: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Bone marrow biopsy: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Bone marrow biopsy: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Biopsy
Description: Bone marrow biopsy: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Bone marrow aspiration: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Bone marrow aspiration: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Bone marrow aspiration: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Bone Marrow Aspiration
Description: Bone marrow aspiration: required at screening/baseline, Phase I post cycle (C)~1(C1Day(D)28 +/- 3 days) and Phase II post cycle 2 (C2D28 +/- 3 days) and post cycle 6 (C6D28 +/- 3days); and if needed clinically in the setting of aplasia or concern for disease progression.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ECG
Description: 12-lead electrocardiogram (ECGs) will be performed at baseline only for safety.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ECG
Description: 12-lead electrocardiogram (ECGs) will be performed at baseline only for safety.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ECG
Description: 12-lead electrocardiogram (ECGs) will be performed at baseline only for safety.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: ECG
Description: 12-lead electrocardiogram (ECGs) will be performed at baseline only for safety.