A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL

NCT ID: NCT05658562

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2028-08-31

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MT-2111 dosing regimen

Group Type: EXPERIMENTAL

MT-2111

Intervention Type: DRUG

i.v. infusion

Interventions

MT-2111

i.v. infusion

Intervention Type: DRUG

Other Intervention Names

Loncastuximab tesirine

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

General Manager

Role: STUDY_DIRECTOR

Tanabe Pharma Corporation

Locations

Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Kyushu Cancer Center

Fukuoka, Fukuoka, Japan

Aso Iizuka Hospital

Iizuka-shi, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Gifu Municipal Hospital

Gifu, Gifu, Japan

Gunma Prefectural Cancer Center

Ota-shi, Gunma, Japan

Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyōgo, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Shinshu University Hospital

Matsumoto-shi, Nagano, Japan

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Nagasaki, Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, Japan

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka, Osaka, Japan

Shimane University Hospital

Izumo-shi, Shimane, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Disaster Medical Center

Tachikawa-shi, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Countries

Japan

Other Identifiers

MT-2111-A-101

Identifier Type: -

Identifier Source: org_study_id