A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects with Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

UVA Tracking #
HSR220315
Principal Investigator
Enrica Marchi
Contact
Contact Phone
Official Trial Title
A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects with Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas. This study is divided into 2 parts: 1) Part A-Dose Escalation and (2) Part B-Cohort Expansion. You will participate in either Part A or Part B depending on when you join the study. The purpose of this study is to find out if various doses of DR-01 can be safely given to subjects with large granular lymphocytic leukemia or cytotoxic lymphomas and if it will result in destroying your cancer cells.

If you are enrolled into Part A of the study, you will be treated with infusions pf varying dose levels of DR-01. The dose level tested may go up or down depending upon the tolerability of the tested dose. If you are enrolled into Part B you will receive the dose level of DR-01 that was determined to be tolerable in Part A.

Your participation in the study consists of a screening period of up to 14 days and, if you are eligible to participate in the study, this will be followed by up to 24 months of treatment and follow-up exams. If your cancer has responded to treatment or has not progressed while on treatment, you may be followed for another 12 months for disease evaluations.

Study-related (insert exams, tests and experimental medication) provided free of charge.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT05475925

Compensation

$100 per visit; Up to $175 per night for hotel