Recruiting
Phase 1

BMS-986497

Sponsor:

Bristol-Myers Squibb

Code:

NCT06419634

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986497

Azacitidine

Venetoclax

Study Details

Brief summary:

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Conditions

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Study ID

NCT06419634

Start date

May 29, 2024

Status verified date

Apr, 2026

Completion date

Sep 16, 2030

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
  • Detectable levels of cluster of differentiation 33 (CD33) expression.
  • Failed alternative therapies with established benefit.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.

Exclusion Criteria:

  • Acute Promyelocytic Leukemia.
  • Clinically active central nervous system leukemia.
  • Active malignant solid tumor.
  • Pregnant or breastfeeding.
  • Other protocol-defined inclusion/exclusion criteria apply.

Study Design

Enrollment

105 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Dose Escalation BMS-986497 (Monotherapy)

experimental: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)

experimental: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)

Interventions

BMS-986497

Specified dose on specified days

Azacitidine

Specified dose on specified days

Venetoclax

Specified dose on specified days

Primary outcome measure

  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Up to 21 days ]
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 2 years ]
  • Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy [ Time Frame: Up to 2 years ]
  • RP2D of BMS-986497 as Combination Therapy [ Time Frame: Up to 2 years ]
  • RP2D of BMS-986497 as Triple Combination Therapy [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Yale-New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Amer Zeidan, Site 0011

203-737-7078

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jessica Altman, Site 0010

312-503-1794

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Rupa Narayan, Site 0014

617-724-3456

Washington University School of Medicine, Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Geoffrey Uy, Site 0013

314-273-1039

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Jamie Koprivnikar, Site 0008

551-996-3925

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Abhishek Maiti, Site 0006

832-696-8407

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Andre Schuh, Site 0002

4168998644

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Sarit Assouline, Site 0003

5143408222x28434

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • BMS-986497
  • First-in-Human
  • ORM-6151
  • Acute myeloid leukemia (AML)
  • Myelodysplastic syndrome (MDS)
  • Cluster of differentiation 33 (CD33)
  • G1 to S phase transition 1 (GSPT1)
  • Open label study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-04-08.