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)

ovartis Pharma AG0 个研究点目标入组 128 人开始时间: 2020年5月29日最近更新: 2022年3月2日

试验速览

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•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

•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.

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