Non-Hodgkins Lymphoma Chronic Lymphocytic Leukemia MedDRA version: 21.0 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 22.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: JBH492
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: not yet established
Current Sponsor code: JBH492
Other descriptive name: JBH492
Concentration unit: mg m
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion 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. Other inclusion criteria may apply. Are the trial subjects under 18? yes Number of subjects for this age range: 3 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 61 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
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 completed > 4 weeks before first dose of study treatment. 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. Patients who received prophylactic intrathecal treatment are eligible, if treatment discontinued >5 half-lives prior to the first dose of study treatment. •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 exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize safety, tolerability, and maximum tolerated dose/recommended dose for expansion of JBH492 single agent in patients with CLL and NHL;Secondary Objective: -To evaluate the preliminary anti-tumor activity of single agent JBH492 in CLL -To evaluate the preliminary anti-tumor activity of single agent JBH492 in NHL -To determine the pharmacokinetics (PK) of single agent JBH492, including total antibody, total ADC, DM4, and sDM4 -To assess the immunogenicity (IG) of JBH492;Primary end point(s): Safety: Incidence and severity of dose limiting toxicities (DLTs), AEs and SAEs, including changes in laboratory values, vital signs and ECGs Incidence and nature of DLTs during the first treatment cycle (dose escalation only) Tolerability: Frequency of dose interruptions, reductions, dose intensity and dose intensity rate;Timepoint(s) of evaluation of this end point: 32 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall response rate (ORR) per iwCLL response criteria, Best overall response (BOR), DOR, i.e. the time from achievement of CR/PR to first documented disease progression or death due to CLL, Progression-freesurvival (PFS) - Overall response rate (ORR) per Lugano criteria. Best overall response (BOR), DOR, i.e. the time from achievement of CR/PR or to first documented disease progression or death due to NHL, Progression-freesurvival (PFS) - PK parameters (e.g. AUC, Cmax, Cmin, Tmax, half-life) for four analytes (total Ab, total ADC, DM4, and sDM4); concentration vs. time profiles of four analytes - Incidence of anti-JBH492 antibodies;Timepoint(s) of evaluation of this end point: 32 months | — |
Countries
Finland, Germany, Israel, Japan, Korea, Republic of, Singapore, Spain, United States
Contacts
Public ContactMedical Information Service
Novartis Finland Oy
Outcome results
None listed