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

ClinicalTrials.gov Identifier: NCT04240704

Novartis Reference Number: CJBH492A12101

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of the First-In-Human study is to assess safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary efficacy of JBH492 as single agent.

Condition 
Non-Hodgkins Lymphoma
Chronic Lymphocytic Leukemia
Phase 
Phase 1
Overall status 
Recruiting
Enrollment count 
120 participants
Start date 
Sep 30, 2020
Completion date 
Jul 07, 2023
Gender 
All
Age(s)
12 Years and older (Child, Adult, Older Adult)

Interventions

Drug
JBH492
Anti-CCR7 antibody-drug conjugate (ADC)

Eligibility Criteria

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, 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 Locations

United States
Mayo Clinic Arizona
Recruiting
Phoenix, 85054
Arizona
United States
Mayo Clinic Rochester
Recruiting
Rochester, 55905
Minnesota
United States
Medical College of Wisconsin
Recruiting
Milwaukee, 53226
Wisconsin
United States
Israel
Novartis Investigative Site
Recruiting
Tel Aviv, 6423906
-
Israel
Japan
Novartis Investigative Site
Recruiting
Chuo ku, 104 0045
Tokyo
Japan
Singapore
Novartis Investigative Site
Recruiting
Singapore, 169608
-
Singapore

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]