Overview
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Eligibility
Inclusion Criteria:
For patients with CLL:
Confirmed diagnosis of chronic lymphocytic leukemia (CLL)
For patients with NHL:
- Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).
- Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
Exclusion Criteria, applicable to both CLL and NHL:
- History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration
- Any prior history of treatment with maytansine (DM1 or DM4)-based ADC
- Known intolerance to a maytansinoid
- Patients with any active or chronic corneal disorders
- Patients who have any other condition that precludes monitoring of the retina or fundus
- Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was > 4 weeks before enrollment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met.
- Impaired cardiac function or clinically significant cardiac disease
- Known history of Human Immunodeficiency Virus (HIV) infection
- Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection
Other inclusion and exclusion criteria may apply.