SAR443579 + Other Agents for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, SAR443579 (also known as IPH6101), for individuals with certain blood cancers that exhibit a marker called CD123. Researchers aim to assess the safety and effectiveness of SAR443579 when combined with other treatments. The trial includes participants with acute myeloid leukemia, a type of blood cancer, who cannot undergo intensive chemotherapy. Participants should have been living with acute myeloid leukemia and must not have certain other health conditions, such as severe heart disease or active infections. 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 treatment.
Do I need to stop my current medications to join the trial?
The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that you should not be on medications with a narrow therapeutic index that are substrates of CYP enzymes unless they can be closely monitored for dose adjustment. Also, you should not have taken strong or moderate CYP3A inducers within 7 days before starting the study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that SAR443579, combined with azacitidine and venetoclax, is under study for safety in people with certain blood cancers. Early results suggest that most patients tolerate the combination well. However, like any treatment, side effects can occur, ranging from mild to severe.
Some patients have experienced side effects, but these are often manageable. Researchers closely monitor participants during the studies to detect any dose-related side effects early. This vigilance helps ensure the treatment remains safe at the recommended dose.
In other studies, venetoclax and azacitidine, components of this combination, have proven safe in similar patient groups. This provides some confidence in the overall safety of the treatment combination.
Potential participants should discuss any concerns with their healthcare provider to help decide if joining a trial is the right choice.12345Why are researchers excited about this trial's treatments?
SAR443579 is unique because it targets blood cancers in combination with azacitidine and venetoclax, aiming to enhance treatment effectiveness. Unlike standard treatments that might focus on just one pathway, this combination approach targets multiple cancer growth mechanisms. Researchers are excited because SAR443579's novel mechanism could potentially improve patient outcomes by attacking blood cancer cells more comprehensively.
What evidence suggests that this trial's treatments could be effective for blood cancers?
Research has shown that combining azacitidine and venetoclax effectively treats certain blood cancers, such as acute myeloid leukemia (AML). These drugs attack cancer cells and inhibit their growth. In this trial, participants will receive a combination of SAR443579, azacitidine, and venetoclax. SAR443579 is a new treatment targeting CD123, a protein found in some blood cancer cells. Early studies suggest that using SAR443579 with azacitidine and venetoclax could improve outcomes for patients with CD123-expressing blood cancers. Initial data indicates this combination might control the disease more effectively than existing treatments alone.36789
Are You a Good Fit for This Trial?
This trial is for adolescents and adults with blood cancers, specifically those expressing CD123, who are seeking new treatments. Participants should be eligible based on specific inclusion criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction and Maintenance
Participants receive SAR443579 in combination with azacitidine and venetoclax for dose finding, optimization, and expansion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SAR443579
SAR443579 is already approved in United States, European Union for the following indications:
- None approved; received FDA Fast Track Designation for the treatment of acute myeloid leukemia
- None approved; currently in clinical trials
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University