A Phase I Study of VLS-101 in People with Blood Cancers

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Full Title

A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects with Hematological Malignancies

Purpose

The purpose of this study is to find the highest dose of the investigational drug VLS-101 that can be given safely in people with blood cancers, such as leukemia and lymphoma, that continue to grow despite treatment. Cancer cells can have a protein on their outer surfaces called ROR1, which is not usually present on normal cells. VLS-101 attaches to ROR1 on a cancer cell and then delivers a small chemotherapy molecule into the cell. 

Preliminary data from studies assessing VLS-101 for certain types of lymphoma have been encouraging, showing it has limited side effects. VLS-101 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have a blood cancer that has continued to grow despite treatment. Examples include chronic lymphocytic leukemia, small lymphocytic lymphoma, marginal zone lymphoma, mantle cell lymphoma, Richter transformation lymphoma, Burkitt lymphoma, lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia, T-cell non-Hodgkin lymphoma, follicular lymphoma, diffuse large B-cell lymphoma, acute lymphocytic leukemia, and acute myeloid leukemia.
  • At least 1 week must pass between the completion of prior treatment and receipt of VLS-101.
  • 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.

For more information about this study and to ask about eligibility, please call the office of Dr. Erel Joffe at 646-608-3703.

Protocol

20-533

Phase

I

Investigator

Co-Investigators