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

UVA Tracking #
HSR230073
Principal Investigator
Enrica Marchi
Contact
Contact Phone
Official Trial 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 L
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who relapsed or refractory lymphomas, large granular lymphocytic leukemia, or solid tumors. There are two parts to this study – Phase 1a and Phase 1b. You can participate in only one of the phases. The study doctor will discuss which treatment groups you may be suitable for. The purpose of the Phase 1a study is to determine the maximum dose of the study drug KT-333 that can be given that is well tolerated by patients with relapsed or refractory (R/R) lymphoma, LGL-L and solid tumors. The purpose of the Phase 1b study is to evaluate the safety and tolerability of the study drug in patients with R/R lymphoma especially Peripheral T-Cell Lymphoma, Cutaneous T-Cell Lymphoma, LGL,-L, and solid tumors. This phase of the study will have these four cancer types into groups called cohorts. This is an open-label study which means you and the study doctor will know what dose of the study drug you will be receiving.

The length of time that you remain on the study will depend on how long you continue on the study drug based on your tolerance and on the disease response. The study drug will be administered every seven days via a slow intravenous infusion. The infusion will be given over approximately 2 hours.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05225584?term=NCT05225584

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation