Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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).

Official Title

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

Details

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.

Keywords

Acute Myeloid Leukemia NTLA-5001 cell kinetics Pharmacodynamics clustered regularly interspaced short palindromic repeats CRISPR AML TCR T Cell Therapy Autologous Leukemia Neoplasms Immune System Diseases Immunoproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Acute Arm 1: NTLA-5001 Arm 2: NTLA-5001

Eligibility

You can join if…

Open to people ages 18 years and up

(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

You CAN'T join if...

(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.

Locations

  • Research Site 2
    Los Angeles California 90095 United States
  • Research Site 6
    Portland Oregon 97239 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intellia Therapeutics
ID
NCT05066165
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 54 study participants
Last Updated