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A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia

Description

Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced neutropenia (CIN) in adult subjects with AML. Eligible subjects with untreated de novo or secondary AML and per local institutional standards planned to receive at least two cycles of chemotherapy with curative intent will be enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC chemotherapy). Subjects randomized to an Investigational Arm will be eligible to receive a single fixed assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle). Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy. All subjects will be followed for 84 days following randomization, or 30 days post final infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control Arm, whichever is longer.

Phase

N/A

Inclusion and Exclusion Criteria

  • Age ≥ 18 (or legal age of majority for sites outside US).
  • Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis
  • Eligible for at least 2 cycles of standard of care AML chemotherapy that will result in moderate to severe myelosuppression and have curative intent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or Karnofsky Status of 50 to 100.
  • Adequate cardiac, renal, and hepatic functions.

  • Extramedullary disease in the absence of bone marrow or blood involvement
  • Acute promyelocytic leukemia (APL) with PML-RARA
  • Prior AML therapy, with the exception of intrathecal chemotherapy or emergent radiation for myeloid sarcoma.
  • Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or radiation
  • Prior allotransplant, including allogeneic hematopoietic cell transplant or solid organ allogeneic transplant
  • Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO)
  • Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection

Sites

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