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

Phase 1

• Conditions: on-Hodgkins LymphomaChronic Lymphocytic Leukemia; MedDRA version: 21.0Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002666-12-FI
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-12
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified