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Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL

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Novartis

Status and phase

Terminated
Phase 1

Conditions

Non-Hodgkins Lymphoma
Chronic Lymphocytic Leukemia

Treatments

Drug: JBH492

Study type

Interventional

Funder types

Industry

Identifiers

NCT04240704
2019-002666-12 (EudraCT Number)
CJBH492A12101

Details and patient eligibility

About

The purpose of the First-In-Human study was to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.

Full description

This was a FIH, open-label, phase I/Ib, multi-center study, which consisted of a dose escalation part of JBH492 as a single agent, followed by an expansion part. The escalation part was conducted in patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and Non-Hodgkin's Lymphoma (r/r NHL). Once the maximum tolerated dose/recommended dose (MTD/RD) of single agent JBH492 was determined, the study continued with an expansion part with single agent JBH492 in defined patient populations.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 completed >4 weeks before first dose of study treatment. 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. Patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued >5 half-lives prior to the first dose of study treatment
  • Impaired cardiac function or clinically significant cardiac disease
  • Known history of Human Immunodeficiency Virus (HIV) infection
  • Active HBV or HCV infection. Patients whose disease is controlled under antiviral therapy should not be excluded. Patients who are anti-HBcAb positive should be HBsAg negative and HBV-DNA negative to be eligible

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

JBH492 single agent
Experimental group
Description:
Patients with R/R CLL or NHL
Treatment:
Drug: JBH492

Trial contacts and locations

8

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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