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

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Novartis Pharmaceuticals
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Updated on 16 February 2024
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HIV Infection
chronic lymphocytic leukemia
lymphoid leukemia
lymphoma
hodgkin's disease
hepatitis
leukemia
immunodeficiency
lymphocytic leukemia
non-hodgkin lymphoma

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.

Details
Condition Lymphoma, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia
Age 12years - 100years
Treatment JBH492
Clinical Study IdentifierNCT04240704
SponsorNovartis Pharmaceuticals
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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

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
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