Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia
NCT ID: NCT05066165
Last Updated: 2023-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
6 participants
INTERVENTIONAL
2021-12-17
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm 1: NTLA-5001
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.
Arm 1: NTLA-5001
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.
Arm 2: NTLA-5001
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.
Arm 2: NTLA-5001
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.
Interventions
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Arm 1: NTLA-5001
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.
Arm 2: NTLA-5001
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy.
Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Intellia Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITL-5001-CL-001
Identifier Type: -
Identifier Source: org_study_id