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CAR T-cell Therapy
NK Cell Therapy for Acute Myeloid Leukemia
Phase 1
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 1 year
Awards & highlights
Study Summary
This trial will look at a drug to treat adults with relapsed or refractory AML after going through chemotherapy.
Who is the study for?
Adults with relapsed or refractory acute myeloid leukemia (R/R AML) who've had at least one prior treatment can join this trial. They must be over 18, weigh at least 42 kg, and not have a history of solid organ transplants or certain infections like HIV/AIDS, hepatitis B/C, or symptomatic COVID-19. Pregnant women and those not using effective contraception are excluded.Check my eligibility
What is being tested?
The study is testing SAR445419 in adults with R/R AML following chemotherapy conditioning with fludarabine and cytarabine. It's a Phase 1 trial to find the right dose based on safety and preliminary effectiveness against leukemia over several weeks including follow-up for up to a year.See study design
What are the potential side effects?
Potential side effects include reactions related to immune cell infusion such as fever, fatigue, headache, nausea; complications from chemotherapy like low blood counts leading to infection risk; plus any unforeseen effects due to the novel nature of SAR445419.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of DLT from start of chemotherapy
Incidence of dose-limiting (DLT) toxicity
Secondary outcome measures
Duration of event-free survival
Duration of response
Median time to neutrophil and platelet count recovery
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SAR445419Experimental Treatment3 Interventions
Treatment consists of chemotherapy with fludarabine 30mg/m2/day and cytarabine 2g/m2/day administered for 5 days (Day -6 to Day -2), followed by 6 doses of SAR445419 given thrice weekly for 2 weeks beginning Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cytarabine
1997
Completed Phase 3
~10270
fludarabine
2012
Completed Phase 3
~6760
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Who is running the clinical trial?
SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,473 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant, including a cornea.I do not have AIDS, HIV needing treatment, active hepatitis B or C, or severe COVID-19.I have another cancer that needs treatment, but hormone therapy is okay.I am not pregnant, breastfeeding, and willing to use effective birth control if of childbearing potential.I am taking more than 10 mg/day of oral prednisone or its equivalent, not including inhalers, nasal sprays, or eye drops.I weigh at least 42 kg.I am not allergic or unable to take fludarabine, cytarabine, acetaminophen, or diphenhydramine.I am 18 years old or older.I have AML that has returned or didn't respond to treatment, including after a stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: SAR445419
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has SAR445419 been sanctioned by the FDA?
"While data is limited, based on our assessment at Power SAR445419 received a score of 1 for safety due to this being an early-stage clinical trial."
Answered by AI
How many participants have voluntarily enrolled in this clinical exploration?
"Affirmative. Clinicaltrials.gov records verify that this research, initially posted on June 16th 2023, is currently seeking participants. To fulfil their needs, 12 individuals must be sourced from 3 disparate medical facilities."
Answered by AI
Is enrollment for this clinical research still open?
"The records on clinicaltrials.gov state that this medical trial is recruiting participants, commencing June 16th 2023 and most recently updated on the 29th of the same month."
Answered by AI
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