A Phase I Study of KT-333 in People with Lymphoma and Large Granular Lymphocytic Leukemia

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Full Title

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Intravenously Administered KT-333 in Adult Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug KT-333 that can be given safely in people with lymphoma or large granular lymphocytic leukemia (LGL-L) that has come back or continued to grow despite prior treatment. KT-333 works by breaking down a protein called STAT3, which helps cancer cells survive. By breaking down STAT3, KT-333 may cause cancer cells to die. It is given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have Hodgkin lymphoma, non-Hodgkin lymphoma, or LGL-L that came back or continued to grow despite at least two prior regimens of therapy.
  • At least 4 weeks must pass between the completion of previous treatment and receipt of KT-333.
  • Participants must have adequate organ function and blood test results.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Zachary Epstein-Peterson at 646-608-4176.

Protocol

22-348

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Co-Investigators

ClinicalTrials.gov ID

NCT05225584