Acute Myeloid Leukemia Clinical Trial

Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

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).

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Full 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.

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Eligibility Criteria

Inclusion Criteria (abbreviated):

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 (abbreviated):

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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT05066165

Recruitment Status:

Terminated

Sponsor:

Intellia Therapeutics

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There are 6 Locations for this study

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Research Site 2
Los Angeles California, 90095, United States
Research Site 5
Tampa Florida, 33612, United States
Research Site 1
Boston Massachusetts, 02114, United States
Research Site 6
Portland Oregon, 97239, United States
Research Site 3
Houston Texas, 77030, United States
Research Site 4
Milwaukee Wisconsin, 53226, 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

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

6

Study ID:

NCT05066165

Recruitment Status:

Terminated

Sponsor:


Intellia Therapeutics

How clear is this clinincal trial information?

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