Clinical Trial Details

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

Categories (click each to see list of all clinical trials associated with that category): Lymphoma/Chronic lymphocytic leukemia (CLL)

Current Status: Open to accrual

Phase: I

Principal Investigator: Kallam, Avyakta

Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu

Eligibility: https://clinicaltrials.gov/ct2/show/NCT03833180?cond=NCT03833180&draw=2&rank=1#eligibility

Summary
Primary Outcome Measures: (1) Maximum tolerated dose (MTD) [ Time Frame: 3 weeks ] Recommended starting dose Secondary Outcome Measures: (1) Plasma VLS-101 drug concentrations [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ] Pharmacokinetics (2) Incidence of adverse events and laboratory abnormalities [ Time Frame: Weekly during the first 6 weeks and then every 3 weeks up to 96 weeks ] Safety (3) Serum concentrations of VLS-101-reactive antibodies [ Time Frame: Weekly during the first 3 weeks and then every 3 weeks up to 96 weeks ] Immunogenicity (4) Tumor response by published criteria (Hallek 2008, Cheson 2014) [ Time Frame: Every 9 to 12 weeks up to 48 weeks and then every 12 to 16 weeks up to 96 weeks ] Efficacy