BMS-986497 for Leukemia and Myelodysplastic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BMS-986497 for individuals with certain blood disorders, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), which are difficult to treat. The researchers aim to determine the safety and effectiveness of the treatment, both alone and in combination with other medications like Azacitidine and Venetoclax. Suitable candidates for this trial include those whose AML or MDS has returned or not responded to other treatments and who have a specific protein (CD33) in their blood. The goal is to identify the optimal dose and assess the treatment's effectiveness in controlling the disease. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMS-986497, also known as ORM-6151, is under study to assess its safety and tolerability in patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The FDA has approved human testing of this treatment, indicating some initial confidence in its safety. However, detailed safety information in humans is not yet available, as it remains in the early stages of testing. The study aims to determine the optimal dose and identify any side effects when used alone or with other drugs like Azacitidine and Venetoclax. This early research is crucial for understanding the safety profile of BMS-986497 and potential side effects.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986497 because it represents a novel approach to treating leukemia and myelodysplastic syndrome. Unlike standard treatments, which often involve chemotherapy or targeted therapies like tyrosine kinase inhibitors, BMS-986497 is being explored for its potential to work as a monotherapy and in combination with other drugs, potentially enhancing its effectiveness. This drug may offer a new mechanism of action that targets specific pathways involved in cancer cell survival, which could lead to better outcomes for patients who have not responded well to existing therapies. The versatility of using BMS-986497 in different therapeutic combinations also opens up possibilities for personalized treatment strategies, offering hope for improved efficacy and reduced side effects.
What evidence suggests that this trial's treatments could be effective for AML or MDS?
Research has shown that BMS-986497 could be a promising treatment for certain types of blood cancer, specifically relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). This trial includes different treatment arms to evaluate BMS-986497. In one arm, participants will receive BMS-986497 alone; early findings suggest it might help reduce cancer cell activity. In other arms, BMS-986497 will be combined with other drugs like Azacitidine, or Azacitidine and Venetoclax, potentially increasing its effectiveness by attacking the cancer in different ways. Although more research is needed, these early results offer hope for those seeking new treatment options.16789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants should have these conditions confirmed and not be responding to standard treatments. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatment history.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of BMS-986497 to assess safety and determine the recommended dose
Dose Expansion
Participants receive the recommended dose of BMS-986497 to further assess safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986497
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania