Acute Myeloid LeukemiaPhase 1NCT06419634
Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Phase 1 study testing BMS-986497, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Bristol-Myers Squibb at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- BMS-986497, Azacitidine and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 29 May 2024to 28 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute Promyelocytic Leukemia.
- Clinically active central nervous system leukemia.
- Active malignant solid tumor.
- Pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States6 sites
Local Institution - 0014
Boston, Massachusetts, 02114
Local Institution - 0010
Chicago, Illinois, 60611
Local Institution - 0008
Hackensack, New Jersey, 07601
Local Institution - 0006
Houston, Texas, 77030
Local Institution - 0011
New Haven, Connecticut, 06510
Local Institution - 0013
St Louis, Missouri, 63108
Canada2 sites
Local Institution - 0003
Montreal, Quebec, H3T 1E2
Local Institution - 0002
Toronto, Ontario, M5G 2M9
Spain2 sites
Local Institution - 0020
Barcelona, Catalunya [Cataluña], 08036
Local Institution - 0023
Seville, 41013
About this study
Official title: Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
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
- Being tested
- BMS-986497, Azacitidine, Venetoclax
- 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
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986497Drug
Also called ORM-6151
Specified dose on specified days
AzacitidineDrug
Specified dose on specified days
VenetoclaxDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation BMS-986497 (Monotherapy) | Experimental | Not described Receives: Drug: BMS-986497 |
| Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) | Experimental | Not described Receives: Drug: BMS-986497; Drug: Azacitidine |
| Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) | Experimental | Not described Receives: Drug: BMS-986497; Drug: Azacitidine; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 21 days
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 years
Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy
Measured: Up to 2 years
RP2D of BMS-986497 as Combination Therapy
The combination therapy included BMS-986497 and Azacitidine
Measured: Up to 2 years
RP2D of BMS-986497 as Triple Combination Therapy
The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
Measured: Up to 2 years
Secondary outcomes (12)
Maximum concentration (Cmax)
Measured: Up to 2 years
Time to reach Cmax (Tmax)
Measured: Up to 2 years
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)
Measured: Up to 2 years
Overall response rate (ORR)
Measured: Up to 4 years
Duration of response (DoR)
Measured: Up to 4 years
Best overall response (BOR)
Measured: Up to 4 years
Complete remission (CR)
Measured: Up to 4 years
Complete remission with incomplete hematologic recovery (Cri)
Measured: Up to 4 years
Complete remission with partial hematologic recovery (CRh) rate
Measured: Up to 4 years
Event-free survival (EFS)
Measured: Up to 4 years
Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)
Measured: Up to 4 years
Incidence of Anti-drug antibody (ADA) against BMS-986497
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start29 May 2024
- Primary completion28 Aug 2026
- Study completion28 Aug 2026
Why it stopped: Inability to meet protocol objectives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419634
- Sponsor's protocol ID
- CA235-0001
- Other IDs
- 2024-519537-29
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
- ClinicalTrials.gov ID
- NCT06419634
- Acronym / sponsor ID
- CA235-0001
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to meet protocol objectives
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 28 Aug 2026 (actual)
- Study completion
- 28 Aug 2026 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation BMS-986497 (Monotherapy) | Experimental | Drug: BMS-986497 |
| Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) | Experimental | Drug: BMS-986497, Drug: Azacitidine |
| Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) | Experimental | Drug: BMS-986497, Drug: Azacitidine, Drug: Venetoclax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Acute Promyelocytic Leukemia.
- Clinically active central nervous system leukemia.
- Active malignant solid tumor.
- Pregnant or breastfeeding.
- Other protocol-defined inclusion/exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986497Also: ORM-6151Specified dose on specified days | Drug | Part 1: Dose Escalation BMS-986497 (Monotherapy), Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy), Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) |
| AzacitidineSpecified dose on specified days | Drug | Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy), Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) |
| VenetoclaxSpecified dose on specified days | Drug | Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) |
Primary outcome
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
The combination therapy included BMS-986497 and Azacitidine
RP2D of BMS-986497 as Triple Combination Therapy
Time frame: Up to 2 years
The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.
12 secondary outcomes
Maximum concentration (Cmax)
Time frame: Up to 2 years
Time to reach Cmax (Tmax)
Time frame: Up to 2 years
Area under the curve from time 0 to last quantifiable concentration (AUC0-last)
Time frame: Up to 2 years
Overall response rate (ORR)
Time frame: Up to 4 years
Duration of response (DoR)
Time frame: Up to 4 years
Best overall response (BOR)
Time frame: Up to 4 years
Complete remission (CR)
Time frame: Up to 4 years
Complete remission with incomplete hematologic recovery (Cri)
Time frame: Up to 4 years
Complete remission with partial hematologic recovery (CRh) rate
Time frame: Up to 4 years
Event-free survival (EFS)
Time frame: Up to 4 years
Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)
Time frame: Up to 4 years
Incidence of Anti-drug antibody (ADA) against BMS-986497
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Inability to meet protocol objectives). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986497, Azacitidine and Venetoclax in people with Acute Myeloid Leukemia and Myelodysplastic Syndrome, run by Bristol-Myers Squibb at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inability to meet protocol objectives). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: Up to 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.