Overview
[Phase I part] To investigate the safety, tolerability, and pharmacokinetics of MT-2111 monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). In addition, the dose to be used in the Phase II part will be confirmed.
[Phase II part] To evaluate the efficacy of MT-2111 monotherapy in patients with relapsed/refractory DLBCL. In addition, the safety and pharmacokinetics will be investigated.
Eligibility
Inclusion Criteria:
- Patients who were diagnosed pathologically with DLBCL, NOS, DLBCL transformed from indolent B-cell lymphoma, or high-grade B-cell lymphoma with DLBCL morphology and with MYC and BCL2 and/or BCL6 rearrangements, based on the 2017 WHO classification.
- Patients with relapsed or refractory disease despite 2 or more prior systemic therapies.
- Japanese patients aged ≥ 18 years at the time of informed consent. For Japanese subjects, it should be confirmed that the parents who are related by blood to the subject must be Japanese.
- Patients who have a lesion that can be assessed for staging and evaluated for response according to the Lugano criteria (2014). A lesion that has received radiotherapy as the most recent treatment will be considered as a measurable lesion only when progression has been documented following completion of the radiotherapy.
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
Exclusion Criteria:
- Patients with a pathological diagnosis of Burkitt's lymphoma.
- Patients with bulky disease with the longest dimension of ≥ 10 cm.
- Patients with a history or complication of post-transplant lymphoproliferative disorders.
- Patients with lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease.
- Patients complicated with other active malignancies or patients with a history of
other malignancies within 3 years before informed consent. However, the following are
- exceptional
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- Non-melanoma skin cancer
- Non-metastatic prostate cancer
- Cervical carcinoma in situ
- Ductal carcinoma in situ or lobular carcinoma in situ
- Patients with clinically significant third space fluid accumulation (e.g., ascites
requiring drainage or pleural effusion requiring drainage or associated with shortness of breath).
- Patients who underwent autologous hematopoietic stem cell transplantation (AHSCT) within 30 days prior to the start of study drug administration (Cycle 1 Day 1).
- For the Phase I part, patients with prior allogeneic stem cell transplantation (Allo-HSCT) before the start of study drug administration (Cycle 1 Day 1). For the Phase II part, patients undergoing Allo-HSCT within 60 days prior to the start of study drug administration (Cycle 1 Day 1).
- Patients who had a positive HIV antigen-antibody test or HIV antibody test.
- Patients positive for HBs antigen, HBc antibody, or HBs antibody. However, patients
who meet any of the following are eligible:
- The patient's HBs antibody positivity is clearly due to vaccination.
- Patients who are positive for HBs antibody and/or HBc antibody with HBV-DNA not detected and agree to undergo HBV-DNA tests once a month from the start of study drug administration to at least 12 months after the completion of study drug administration.
- Patients positive for HCV antibody. However, patients with negative HCV-RNA are
eligible.
- Patients who received anticancer therapy during the following periods prior to the
start of study drug administration (Cycle 1 Day 1).
- Cytotoxic chemotherapy: within 14 days.
- Antibody therapy: within 5 half-lives or 14 days, whichever is longer (including monoclonal antibody preparations, radioimmunoconjugates, or antibody-drug conjugates). Within 14 days for rituximab.
- Radiotherapy: within 14 days
- CAR-T therapy: within 100 days
- Other anticancer therapy: within 14 days
- Patients who received treatment with any other investigational product within 14 days
prior to the start of study drug administration (Cycle 1 Day 1). However, for the Phase I part, patients who received any other investigational product within 14 days or 5 half-lives, whichever is longer, before the start of study drug administration (Cycle 1 Day 1).