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Clinical Trial 21435

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05066165

Phase: Phase I/II
Prinicipal Investigator: Sallman, David

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Overview

Study Title

Phase 1/2a, Single Dose 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).

Objective

Primary: Dose Escalation: To identify dose for use in the expansion cohorts Dose Expansion: To evaluate the safety and tolerability of NTLA-5001 in subjects with AML and lower disease burden (Arm 1) and in subjects with AML and higher disease burden (Arm 2) Secondary: -To characterize the cell kinetics (CK) of NTLA-5001 in peripheral blood -To estimate the anti-tumor activity of NTLA-5001 in subjects with AML Exploratory: -To estimate other cancer-related outcomes in subjects with AML -To characterize subject AAV exposure -To characterize immunologic parameters and characteristics of NTLA-5001 cells after administration in subjects with AML

Treatments

Therapies

Chemotherapy (NOS); Therapy (NOS)

Medications

NTLA-5001 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Inclusion Criteria

  • Has AML as defined by World Health Organization
  • 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 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.

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