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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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ primary dlt assessment from ntla-5001 infusion up to 28 days post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~primary dlt assessment from ntla-5001 infusion up to 28 days post-infusion
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 moreTrial 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.
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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.
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