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CAR T-cell Therapy

AMG 553 for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a new drug, AMG 553, to see if it is safe and works well in people with a certain type of leukemia.

Eligible Conditions

Relapsed/Refractory Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Dose limiting toxicities (DLTs)

Treatment-emergent adverse events

Treatment-related adverse events

Secondary outcome measures

Complete response (CR)

Complete response with incomplete recovery of peripheral blood counts (CRi)

Complete response with partial recovery of peripheral blood counts (CRh)

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Comparison of different cell doses of AMG 553Experimental Treatment1 Intervention

Subjects will receive IV infusion of AMG 553

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Who is running the clinical trial?

AmgenLead Sponsor

1,369 Previous Clinical Trials

1,386,456 Total Patients Enrolled

MDStudy DirectorAmgen

912 Previous Clinical Trials

923,989 Total Patients Enrolled

Frequently Asked Questions

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

Are there any adverse effects associated with the use of AMG 553?

"Currently, the safety of AMG 553 is rated as a 1 due to it being in Phase 1 trials. Thus far, there is scant research on its efficacy and safety profiles."

Answered by AI

Is this particular research study currently enrolling participants?

"As per clinicaltrials.gov, the recruiting period for this medical trial has ended; initial posting was March 13th 2023 and it was last updated on December 22nd 2021. Nonetheless, currently there are over a thousand other studies actively seeking patients to join them."

Answered by AI

What objectives are expected to be accomplished through this experiment?

"According to Amgen, the primary outcome measured over a 3 month period is adverse reactions associated with treatment. There are also several secondary outcomes including MRD negative response through flow cytometry and CRh, CIi as per modified IWG criteria, overall complete responses (CR), and morphologic leukemia-free state (MLFS) due to AMG 553's anti-leukemic activity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML

2023. "Study Evaluating the Safety, Tolerability, and Efficacy of FLT3 CAR-T AMG 553 in FLT3-positive Relapsed/Refractory AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03904069.