a study of mt-2111 in patients with relapsed/refractory dlbcl

Conditions: Diffuse Large B-Cell Lymphoma

Summary: \[phase i part\] 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 criteria:
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: * 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, anti-cd3/cd20 bispecific antibody. * 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).