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-413 in Adult Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

UVA Tracking #
HSR210518
Principal Investigator
Michael E. Williams
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-413 in Adult Patients with Relapsed or Refractory B-ce
Study Description

The University of Virginia Comprehensive Cancer Center seeks adult patients ages 18 and over with relapsed or refractory B-Cell Non-Hodgkins Lymphoma(NHL) for a research study. This study consists of two parts (phase 1a and phase 1b). You are being asked to participate in phase 1a. This part of the study is being conducted to find the maximum tolerated dose of a new investigational drug, KT413 (study drug).

If you are eligible to participate, you will receive the study drug as a slow injection into a vein in your arm (infusion). The infusion will be given over approximately 60 minutes. The infusion will be administered following one of two schedules: Schedule 1 (Day 1, every 21 days) or Schedule 2 (Day 1 and Day 2, every 21 days). Each 21-day period is called a Cycle. The study will include multiple 21-day cycles. Your doctor will let you know which schedule you will follow. During the study, the dose of the study drug may be changed (reduced or increased) depending on your body’s response to the study drug and data obtained from the study.

After you finish your study treatment, you will be continued to be contacted approximately every 3 months up to 1 year to collect details of your disease status and other therapies that you might be taking.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to your or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05233033

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

None