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Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

Phase 1/2a, Single Dose Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

NCT05066165•Intellia Therapeutics

Summary

This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK), activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia (AML).

Detailed Description

This 2-part first in human (FIH) study is comprised of two open-label arms. It is a multi-center, Phase 1/2a study evaluating the safety and activity of NTLA-5001 in subjects with persistent or recurrent Acute Myeloid Leukemia after first-line or later therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has AML as defined by World Health Organization
•Has detectable disease following first-line therapy
•Is ≥ 18 years of age.
•Carries the human leukocyte antigen-A0201 (HLA-A\*02:01) allele.
•Has ECOG performance status of 0 to 1.
•Has adequate absolute total lymphocyte count
•Has adequate cardiac, renal, and liver organ function

Exclusion Criteria

•Has received AML-directed therapy or immunomodulatory therapy within a specified window prior to study entry.
•Has received allogeneic hematopoietic cell transplant within 84 days, with ongoing GVHD, with recent DLI, or on active immunosuppression.
•Has CNS involvement by tumor.
•Has severe autoimmunity requiring immunomodulatory therapy.
•Has active disseminated intravascular coagulation (DIC), bleeding or coagulopathy.
•Has leukocytosis ≥ 20,000 blasts/μL despite hydroxyurea or has rapidly progressive disease
•Has human immunodeficiency virus (HIV) infection, or any uncontrolled infection.
•Female subjects are pregnant or breastfeeding; or are of childbearing potential and are unwilling to use protocol specified method of contraception.
•Male subjects who have female partners of childbearing potential and are unwilling to use protocol specified method of contraception.

Locations (10)

Research Site 2

Los Angeles, California, United States

Research Site 5

Tampa, Florida, United States

Research Site 1

Boston, Massachusetts, United States

Research Site 6

Portland, Oregon, United States

Research Site 3

Houston, Texas, United States

Research Site 4

Milwaukee, Wisconsin, United States

Research Site 10

Leeds, United Kingdom

Research Site 8

London, United Kingdom

Research Site 9

London, United Kingdom

Research Site 7

Manchester, United Kingdom

Key Dates

Start Date

December 17, 2021

Primary Completion Date

July 21, 2022

Completion Date

August 31, 2022

Last Updated

December 28, 2023

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

Arm 1: NTLA-5001

GENETIC

Arm 2: NTLA-5001

GENETIC

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RECRUITINGPHASE2

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Acute Myeloid Leukemia

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A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2