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Gene Editing Therapy

Arm 1: NTLA-5001 for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Intellia Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has AML as defined by World Health Organization
Has detectable disease following first-line therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up primary dlt assessment from ntla-5001 infusion up to 28 days post-infusion
Awards & highlights

Study Summary

This trial will study the effects of a new drug, NTLA-5001, on people with a certain type of blood cancer.

Eligible Conditions
  • Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary dlt assessment from ntla-5001 infusion up to 28 days post-infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and primary dlt assessment from ntla-5001 infusion up to 28 days post-infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants That Experienced Dose-limiting Toxicities (DLTs)
Secondary outcome measures
Disease Progression in Participants With AML
Frequency of NTLA-5001 T-cell Receptor (TCR) Transgene Copy Number in the Peripheral Blood
Persistence of NTLA-5001 T Cell Receptor (TCR) Transgene Copy in Peripheral Blood
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: NTLA-5001Experimental Treatment1 Intervention
Up to three escalation cohorts in phase 1 followed by one expansion cohort in phase 2. Subjects have AML and bone marrow blast count ≥5%, administered by IV infusion following lymphodepleting chemotherapy.
Group II: Arm 1: NTLA-5001Experimental Treatment1 Intervention
Up to three escalation cohorts in phase 1 followed by one expansion cohort in phase 2. Subjects have AML and bone marrow blast count <5%, administered by IV infusion following lymphodepleting chemotherapy.

Find a Location

Who is running the clinical trial?

Intellia TherapeuticsLead Sponsor
5 Previous Clinical Trials
1,046 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2025