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New hope for aggressive lymphoma: drug MT-2111 under trial

NCT ID NCT05658562

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called MT-2111 (loncastuximab tesirine) in people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to at least two prior treatments. The trial has two parts: first, to find a safe dose, and second, to see if the drug can shrink tumors. It involves 46 participants in Japan.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT-2111 (loncastuximab tesirine), a drug given by IV infusion
What this could lead to
If successful, this could offer a new treatment option for patients with hard-to-treat DLBCL, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial with only 46 participants, so results may not apply broadly. The drug may cause side effects or fail to improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

46 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Aso Iizuka Hospital

    Iizuka-shi, Fukuoka, 820-8505, Japan

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, 135-0063, Japan

  • Disaster Medical Center

    Tachikawa-shi, Tokyo, 190-0014, Japan

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8513, Japan

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma, 373-8550, Japan

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, Nagasaki, 852-8104, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyōgo, 670-8540, Japan

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

    Osaka, Osaka, 530-0025, Japan

  • Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Osaka Saiseikai Nakatsu Hospital

    Osaka, Osaka, 530-0012, Japan

  • Shimane University Hospital

    Izumo-shi, Shimane, 693-8501, Japan

  • Shinshu University Hospital

    Matsumoto-shi, Nagano, 390-8621, Japan

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677, Japan

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585, Japan

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