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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2024-09-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JBH492 single agent

Patients with R/R CLL or NHL

Group Type EXPERIMENTAL

JBH492

Intervention Type DRUG

Anti-CCR7 antibody-drug conjugate (ADC)

Interventions

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JBH492

Anti-CCR7 antibody-drug conjugate (ADC)

Intervention Type DRUG

Eligibility Criteria

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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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No