All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Chronic Lymphocytic Leukemia
Sep 09, 2020
Sep 30, 2020
Jul 07, 2023
12 Years and older (Child, Adult, Older Adult)
Anti-CCR7 antibody-drug conjugate (ADC)
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