Overview

Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL)

Status:
Recruiting
Trial end date:
2023-06-15
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
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.