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BCL-2 inhibitor

SAR443579 for Leukemia

Phase 1 & 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of CD123 + HR-MDS with IPSS-R risk category of intermediate or higher

Body weight at least 10 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

Study Summary

This trial is testing a new drug, SAR443579, to see if it is safe and effective against leukemia.

Who is the study for?

This trial is for children and adults with certain blood cancers like AML, B-ALL, HR-MDS, or BPDCN that have come back or didn't respond to treatment. Participants must be at least 12 years old, weigh over 40 kg, and not have any treatments left that could help them. They can't join if they've had specific prior therapies like CAR-T or anti-CD123 agents, active infections including HIV/AIDS or hepatitis B/C, severe heart issues, poor physical condition (ECOG >2), autoimmune diseases needing strong medication, other active cancers requiring treatment (except some skin cancers), are pregnant/breastfeeding or legally institutionalized.Check my eligibility

What is being tested?

The study tests SAR443579 infusion's safety and effectiveness against various blood-related cancers in a Phase 1/Phase 2 trial. It involves gradually increasing the dose to find the safest amount that works best (dose escalation) and then giving it to more people at this dose level (dose expansion).See study design

What are the potential side effects?

While specific side effects of SAR443579 aren't listed here due to its novel status as a first-in-human study drug; generally such drugs may cause immune system reactions leading to inflammation in different body parts, potential organ damage depending on where the reaction occurs along with common chemotherapy-associated risks like fatigue, nausea and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is HR-MDS with intermediate or higher risk.

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My body weight is at least 10 kg.

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I am between 1 and 17 years old.

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I have been diagnosed with AML, but not APL or JMML.

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My leukemia is CD123 positive without cancer outside the bone marrow.

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I am at least 1 year old or my child is, and I can sign the consent form.

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I am 12 years old or older.

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I have been diagnosed with BPDCN as per the latest WHO guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose-limiting toxicity (DLT) (Escalation Part)

Proportion of participants who have a CR (Complete Remission) + CRi (Complete Remission with Incomplete Hematological Recovery) (Expansion Part)

Secondary outcome measures

Anti-leukemic activity as define by International Working Group (IWG) for AML (modified) and MDS, or National Comprehensive Cancer Network (NCCN) for B-ALL (Escalation Part)

Cmax: Maximum observed concentration

Incidence of anti-drug antibody (ADA) (Escalation and Expansion Parts)

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAR443579Experimental Treatment1 Intervention

Dose Escalation: SAR443579 administered intravenously at escalating dose levels. Dose Expansion: SAR443579 administered intravenously at the recommended dose and schedule determined from the dose escalation.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,854 Total Patients Enrolled

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,713 Total Patients Enrolled

Media Library

SAR443579 (BCL-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05086315 — Phase 1 & 2

Myelodysplastic Syndrome Research Study Groups: SAR443579

Myelodysplastic Syndrome Clinical Trial 2023: SAR443579 Highlights & Side Effects. Trial Name: NCT05086315 — Phase 1 & 2

SAR443579 (BCL-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086315 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are eligible for this clinical trial?

"That is correct. Clinicaltrials.gov reveals that the experiment, which was launched on December 8th 2021, is currently signing up participants. Altogether 82 volunteers need to be brought in from 4 different medical sites."

Answered by AI

Are participants able to join this experiment at the present moment?

"Based on the information provided through clinicaltrials.gov, this trial is actively recruiting participants. Originally launched in December 2021, it was last updated in October 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

2021. "First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05086315.

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