PK, PD, Safety, Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Non-Hodgkin's B-Cell Lymphoma and B-Cell Chronic Lymphocytic Leukemia

Official Title

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Non-Hodgkin's B-Cell Lymphoma and B-Cell Chronic Lymphocytic Leukemia

Summary:

This Phase I, multiple ascending dose study will seek to enroll subjects with progressive B cell non-Hodgkin's lymphoma with measurable disease (lesion > 1.5 cm) (including SLL) OR relapsed/refractory B-cell CLL who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab)) containing front-line regimen that resulted in initial response, followed by relapse/recurrence and who are not eligible for any further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from any therapy of higher priority by Investigator assessment.

Trial Description

Primary Outcome:

  • Tolerability as measured by number of subjects with dose limiting toxicities
  • Safety as measured by number of subjects with Adverse Events using CTCAE
  • Tolerability as measured by adverse events using CTCAE and clinical laboratory parameters
Secondary Outcome:
  • PK as measured by concentrations of free MT-3724 (Cmax, AUC, tmax, Cinf)
  • PD as measured by clinical symptoms, tumour response, immunogenicity
  • Tumour Response as measured by PET or CT scan
This is a two-part study intended to provide investigators and sponsor with the following information regarding the investigational new drug MT-3724: Part 1[COMPLETED]: in patients with relapsed/refractory non-Hodgkin's B cell lymphoma (including SLL) OR relapsed/refractory B-cell CLL 1. The maximum dose of a single course of MT-3724 given as intravenous (IV) infusions on Days 1, 3, 5, 8, 10 and 12 at which there are negligible side effects and/or at which maximum serum levels and/or at which maximum effect on blood lymphocytes are observed. Six dose levels will be investigated. 2. The changes in MT-3724 serum levels and blood lymphocytes over time following IV doses at different points in the study. 3. The changes and kinds of clinical and laboratory effects and side effects that may occur over repeated courses of MT-3724. 4. The changes in each subject's immune status and their non-Hodgkin's lymphoma following one or more cycles of 6 infusions. Part 2: An expansion of the maximum tolerated dose cohort in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) 1. Identify the frequency of nature of clinical and laboratory adverse events that may occur over repeated courses of MT-3724 at the maximum tolerated dose. 2. Define the PK and PD profiles of MT-3724 at the maximum tolerated dose.

View this trial on ClinicalTrials.gov

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Resources

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