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

Trial number:
NCT04240704
Trial phase:
1
Study type:
Chemotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

September, 2020

Scientific title

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)

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.

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.

, 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 administrationAny 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.

Study design

Primary purpose: Treatment, Allocation: N/A, Intervention model: Single Group Assignment, Masking: None (Open Label),

Conditions

Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia

Other study ID numbers

CJBH492A12101

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