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

Clinical Trial Details

This clinical trial is for men and women age 18 and older with previously treated CLL/SLL, MCL, FL, MZL, DLBCL, or RTL. Relapsed or refractory hematological cancers are serious, disabling, and life-threatening disorders. Existing therapies can induce prolonged regressions but typically lose effectiveness over time. New therapies with new mechanisms of action are needed to overcome disease resistance and improve outcomes. 

ROR1 expression offers a cancer-specific marker in several hematological cancers. Through selective targeting of ROR1-positive tumor cells, VLS-101 may safely improve clinical outcomes for patients with previously treated hematological cancers. The potential for beneficial clinical efficacy of VLS-101 against ROR1-positive cancers is well founded on evaluation of its therapeutic effects in relevant in vitro and in vivo efficacy models. 

The purpose of this study is to determine the maximum tolerated dose and/or recommended dosing regimen of VLS-101 in previously treated hematological malignancy patients. 

  • A cycle is 3 weeks 
  • VLS-101 will be administered cyclically in repeated 3-week cycles with each IV drug infusion being given on the first day of each cycle. 
  • Cohorts of subjects will be sequentially enrolled at progressively higher starting dose levels of VLS-101 
  • Subjects may receive VLS-101 therapy indefinitely until disease progression or another one of the study’s discontinuation criteria are met. 

    

Key Eligibility: 
  • Men and women age 18 and older 
  • Histologically confirmed diagnosis of CLL/SLL, MCL, FL, MZL, DLBCL, or RTL 
  • Hematological cancer has been previously treated and has progressed during or relapsed after prior systemic therapy. 
  • Detailed eligibility reviewed when you contact the study team. 

    

Contact

Amelyn Rodriguez, RN
amr2017@med.cornell.edu
212-746-1362

Primary Investigator

Richard Furman, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1810019640

Status:

Not Yet Recruiting

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

1