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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 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 1 year 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 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 more

Trial 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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,170 Previous Clinical Trials
3,516,573 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
864 Previous Clinical Trials
2,020,387 Total Patients Enrolled

Media Library

SAR445419 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05712278 — Phase 1
Acute Myeloid Leukemia Research Study Groups: SAR445419
Acute Myeloid Leukemia Clinical Trial 2023: SAR445419 Highlights & Side Effects. Trial Name: NCT05712278 — Phase 1
SAR445419 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712278 — Phase 1
~4 spots leftby Jun 2025
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