Clinical trial · Interventional
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
NCT05066165CI-TRIAL-00072617terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pivoting to an allogeneic version of this program currently in preclinical development.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1: NTLA-5001 | Genetic | — | UNRESOLVED |
| Arm 2: NTLA-5001 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: NTLA-5001
- description
- 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.
- interventionNames
- Genetic: Arm 1: NTLA-5001
- type
- EXPERIMENTAL
- label
- Arm 2: NTLA-5001
- description
- 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.
- interventionNames
- Genetic: Arm 2: NTLA-5001
Primary outcomes (1)
- measure
- Participants That Experienced Dose-limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.