Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)
ClinicalTrials.gov Identifier: NCT04240704
Novartis Reference Number: CJBH492A12101
Last Update: Nov 03, 2020
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.
Study Description
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Interventions
Eligibility Criteria
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]