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

Trial number: NCT04240704
Trial phase: 1 Study type: chemotherapy, targeted 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 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 Design

Primary purpose: Treatment , Allocation: Non-Randomized , Intervention model: Single Group Assignment , Masking: None (Open Label),

Conditions

Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukemia

Other Study ID Numbers

CJBH492A12101

Locations

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