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MT-3724_NHL_001: Safety, pharmacodynamics and efficacy of MT-3724 for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Description

The purpose of this study is to evaluates the efficacy of MT-3724 (part 3 only).

In Part 3 of this study, the primary objectives will be to determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for lymphoma adjusted according to lymphoma response to immunomodulatory therapy criteria (LYRIC) hereinafter referred to as “revised Lugano Criteria” (Cheson et al, 2014, 2016).

The overall response rate is defined as the proportion of subjects with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review.

Status

Accepting new patients

Primary Study Objective(s)

The purpose of this study is to evaluates the efficacy of MT-3724 (part 3 only).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Have relapsed or refractory diffuse large B-cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification
  • Have received at least two standard-of-care regimens for non-Hodgkin lymphoma treatment
  • Have at least one tumor lesion at screening
  • Have a life expectancy of more than three months from the start of treatment
  • Have ECOG performance status of 0-2
  • Have adequate kidney function
  • Have QTcF (Fridericia) ≤480 ms determined as the average of three QTcF values from the triplicate ECG obtained at screening
  • Have LVEF ≥45% by MUGA or echocardiogram obtained at screening
  • Are not be pregnant (Male and female subjects with reproductive potential must agree to use acceptable contraceptive methods until the end of study visit.)
  • Can comply with all study-related procedures and medication use

Excluding patients who:

  • Received any amount of anti-CD20 MAb within the following periods before the start of treatment:
    • Rituximab (Rituxan®/MabThera® or rituximab biosimilar): if administered within 12 to 37 weeks before the start of treatment, then serum rituximab level must be assessed during the screening and confirmed as negative (<500 ng/mL)
    • Obinutuzumab (Gazyva®/Gazyvaro®): 184 days
    • Ofatumumab (Arzerra®): 88 days
  • Received approved or investigational treatment for non-Hodgkin lymphoma (except anti-CD20 MAb and radioimmunoconjugates) within four weeks before the start of treatment (Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.)
  • Received radiation therapy to target lesions within four weeks before the start of treatment, unless the lesions exhibited objective progression between radiation therapy and screening (Palliative radiation therapy to non-target lesions within four weeks before the start of treatment may be permitted at the investigator's discretion.)
  • Received systemic immunosuppressive agents (except prescribed corticosteroids at doses ≤20 mg/day prednisone equivalent) within two weeks before the start of treatment
  • Received any vaccines except injectable flu (inactivated or recombinant) vaccine within four weeks before the start of treatment, or likely to require any vaccines except injectable flu vaccine at any time from the start of treatment until 28 days after the last dose of MT-3724
  • Received allogeneic stem cell transplant
  • Have evidence of CTCAE Grade ≥2 (significant) 1 toxicity before the start of treatment, except for hair loss and those significant toxicities permitted in other eligibility criteria. Subjects with significant permitted in other eligibility criteria
  • Have a history or current evidence of significant infection, systemic infection or wound within two weeks before the start of treatment. (Subjects with significant infection that has stabilized or improved with oral antibiotics before the start of treatment may be eligible at the investigator's discretion.)
  • Have known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation
  • Have current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses >20 mg/day prednisone equivalent
  • Have known active Hepatitis C, HIV or a present history of Hepatitis B
  • Have current evidence of incomplete recovery from surgery or radiotherapy at screening, or planned surgery or radiotherapy from the start of treatment until the short-term follow-up visit, except minor elective surgery or palliative radiation therapy to non-target lesions deemed acceptable by the investigator
  • Have a history of cardiovascular, renal, hepatic or any other disease within three months before the start of treatment
  • Have a history of another primary malignancy within the past three years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) that required systemic drug therapy or radiotherapy
  • Have current evidence of new or growing brain or spinal metastases during screening
  • Are pregnant or breastfeeding
  • Have a history of non-adherence to the schedule of procedures or medication use