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A Study of MT-2111 in Patients With Relapsed/Refractory DLBCL | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Phase I/II Open-Label Study of MT-2111 in Patients With Relapsed/Refractory DLBCL

NCT05658562•Tanabe Pharma Corporation

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+14 more criteria

Locations (23)

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

Key Dates

Start Date

January 30, 2023

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2028

Last Updated

February 13, 2026

Enrollment

ACTUAL participants

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

MT-2111

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE3

A Long-term Extension Study of PCI-32765 (Ibrutinib)

NCT01804686

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Long-term Follow up Local Registry Study of Kymriah in South Korea

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms