NCT04240704

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

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Non-Hodgkins Lymphoma
• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	JBH492	Anti-CCR7 antibody-drug conjugate (ADC)

Timeline

• Start date: 2020-09-07
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2020-01-27
• Last updated: 2025-10-10

Locations

8 sites across 7 countries: Finland, Germany, Israel, Japan, Singapore, South Korea, Spain

Regulatory

• FDA-regulated drug study