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

NCT04240704 | Terminated Phase 1 FDA Drug

• 2 other identifiers: CJBH492A121012019-002666-12
• Study Type: interventional
• Target: 25
• Locations: 7 countries
• Sites: 8

Brief 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.

Conditions

Non-Hodgkins Lymphoma; Chronic Lymphocytic Leukemia

Keywords

CLL; NHL; CCR7; JBH492; ADC; Chronic Lymphocytic Leukemia; Non-Hodgkins Lymphoma

Outcome Measures

Primary Outcomes (6)

• Incidence and severity of dose limiting toxicities (DLTs)

  A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value that occurs during the first cycle of treatment with JBH492 and meets any of the protocol specified criteria, unless incontrovertibly related to underlying disease, intercurrent illness or concomitant medications.

  32 months

• Incidence and severity of Adverse Events (AEs)

  An adverse event ( treatment emergent) is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.

  32 months

• Incidence and severity of Serious Adverse Events (SAEs)

  A Serious adverse event (SAE) is defined as one of the following: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Is medically significant * Requires inpatient hospitalization or prolongation of existing hospitalization.

  32 months

• Number of patients with dose interruptions

  Tolerability measured by the number of subjects who have interruptions of study treatment and reason for interruptions

  32 months

• Number of patients with dose reductions

  Tolerability measured by the number of subjects who have reductions of study treatment and reason for reductions

  32 months

• Dose intensity

  Tolerability measured by the dose intensity of study drug, Relative Dose intensity for subjects with non-zero duration of exposure is computed as the ratio of dose intensity and planned dose intensity

  32 months

Secondary Outcomes (11)

• Overall response rate (ORR)

  32 months

• Best overall response (BOR)

  32 months

• Duration of Response (DOR)

  32 months

• Progression Free Survival (PFS)

  32 months

• Pharmacokinetics (PK) parameter AUClast

  32 months

Study Arms (1)

JBH492 single agent

EXPERIMENTAL

Patients with R/R CLL or NHL

Drug: JBH492

Interventions

JBH492 DRUG

Anti-CCR7 antibody-drug conjugate (ADC)

JBH492 single agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Novartis Investigative Site

Helsinki, FIN-00029, Finland

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 104 0045, Japan

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Seoul, 03080, South Korea

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Related Links

• Link to study results
• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: September 7, 2020
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FI (1); SG (1); IL (1); KR (1); JP (1); DE (2)