Diffuse Large B-Cell LymphomaPhase 1/2NCT05658562

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

A Phase 1/2 study testing MT-2111 in people with Diffuse Large B-Cell Lymphoma, run by Tanabe Pharma Corporation at 23 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diffuse Large B-Cell Lymphoma
What is being tested?: MT-2111
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: 23 sitesJapan
Study dates: 30 Jan 2023to Aug 2028
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 24Show fewer

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).

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Japan23 sites

Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Gifu Municipal Hospital
Gifu, Gifu, 500-8513
Japanese Red Cross Society Himeji Hospital
Himeji-shi, Hyōgo, 670-8540
Aso Iizuka Hospital
Iizuka-shi, Fukuoka, 820-8505
Shimane University Hospital
Izumo-shi, Shimane, 693-8501
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-0063
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Shinshu University Hospital
Matsumoto-shi, Nagano, 390-8621
Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki, Nagasaki, 852-8104
Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, 466-8650
Osaka Saiseikai Nakatsu Hospital
Osaka, Osaka, 530-0012
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka, Osaka, 530-0025
Gunma Prefectural Cancer Center
Ota-shi, Gunma, 373-8550
Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Tohoku University Hospital
Sendai, Miyagi, 980-8574
Disaster Medical Center
Tachikawa-shi, Tokyo, 190-0014
Yamagata University Hospital
Yamagata, Yamagata, 990-9585
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515

Other trials in Japan

About this study

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

[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
Being tested: MT-2111
Medical subject headings: Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-2111Drug
Also called Loncastuximab tesirine
i.v. infusion

Study groups in NCT05658562
Study group	Role	What they receive
MT-2111 dosing regimen	Experimental	Not described Receives: Drug: MT-2111

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall response rate (ORR) by independent central review
Measured: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)

Secondary outcomes (13)

Duration of response (DOR)
Measured: The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
Complete response rate (CRR)
Measured: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Overall survival (OS)
Measured: The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
Progression-free survival (PFS)
Measured: The time from the date of first dose until PD or death (Up to 48 months)
Relapse-free survival (RFS)
Measured: The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
Adverse events and adverse drug reactions
Measured: From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG (Eastern Cooperative Oncology Group) Performance Status is scored on a 6-point scale where higher scores indicate a worse outcome.
Measured: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Body weight
Measured: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (heart rate)
Measured: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram [RR, PR, QRS, QT (QTcF)]
Measured: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (presence or absence of abnormal findings)
Measured: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Serum drug concentration
[Phase 1 part] Cycle 1 [each cycle is 3 weeks (21 days) in duration]: Day 1, 2, 5, 8 and 15, Cycle 2: Day 1, 2, 8 and 15, Cycle 3: Day 1 and 8, odd number Cycle: Day 1,end of treatment (EOT)*, and 15 weeks after the last dose [Phase 2 part] Cycle 1 and 2: Day 1, 8 and 15, odd number Cycle : Day 1, EOT*, and 15 weeks after the last dose
*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Measured: Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.
Anti-drug antibodies (including neutralizing antibodies)
[Phase 1 part] Cycle 1 [each cycle is 3 weeks (21 days) in duration]: Day 1 and 15, Cycle 2: Day 1, odd number Cycle: Day 1, end of treatment (EOT)*, and 15 weeks after the last dose [Phase 2 part] Cycle 1: Day 1 and 15, Cycle 2: Day 1, odd number Cycle : Day 1, EOT*, and 15 weeks after the last dose
*: After the decision to discontinue treatment with study drug and prior to the start of any new anticancer therapy, the scheduled evaluations will be performed preferably 30 days after the last dose of study drug.（Up to 13 months after the first treatment）
Measured: Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 2023Aug 2028

First posted20 Dec 2022
Study start30 Jan 2023
Primary completionAug 2028 (estimated)
Study completionAug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05658562
Sponsor's protocol ID: MT-2111-A-101
Other IDs: jRCT2021220031
Status last verified: Jun 2026
First submitted: 7 Nov 2022
Last updated: 9 Jun 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.tanabe-pharma.com/en/develop/protocol.html

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Open-Label Study of MT-2111 in Patients With Relapsed/Refractory DLBCL
ClinicalTrials.gov ID: NCT05658562
Acronym / sponsor ID: MT-2111-A-101
Conditions: Diffuse Large B-Cell Lymphoma
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 46 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: 30 Jan 2023 (actual)
Primary completion: Aug 2028 (estimated)
Study completion: Aug 2028 (estimated)
First posted: 20 Dec 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

[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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MT-2111 dosing regimen	Experimental	Drug: MT-2111

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (24 listed)

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:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-2111Also: Loncastuximab tesirinei.v. infusion	Drug	MT-2111 dosing regimen

Primary outcome

Overall response rate (ORR) by independent central review
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)

13 secondary outcomes

Duration of response (DOR)
Time frame: The time from the date of first observation of complete response (CR) or partial response (PR) until progressive disease (PD) or death in patients with CR or PR observed (Up to 48 months)
Complete response rate (CRR)
Time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)
Overall survival (OS)
Time frame: The time from the date of first dose until death regardless of the occurrence of intercurrent event (Up to 48 months)
Progression-free survival (PFS)
Time frame: The time from the date of first dose until PD or death (Up to 48 months)
Relapse-free survival (RFS)
Time frame: The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)
Adverse events and adverse drug reactions
Time frame: From the start of premedication until 15 weeks after the last dose of the study drug or until the start of new anticancer therapy, whichever comes first.
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Body weight
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (heart rate)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram [RR, PR, QRS, QT (QTcF)]
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
12-lead electrocardiogram (presence or absence of abnormal findings)
Time frame: Screening to end of treatment (up to 30 days after the last dose) or data cut off
Serum drug concentration
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1, 2*, 5*, 8, and 15. Cycle 2: Days 1, 2*, 8, and 15. Cycle 3: Days 1 and 8*. Odd numbered Cycles: Day 1. End of treatment (up to 13 months after first dose), 15 weeks after the last dose. *Phase 1 only.
Anti-drug antibodies (including neutralizing antibodies)
Time frame: Cycle 1 (each cycle is 3 weeks): Days 1 and 15. Cycle 2: Day 1. Odd numbered cycles: Day 1. End of Treatment (up to 13 months after first dose) and 15 weeks after the last dose.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Individual participant dataSharing planned: Yes. When requested by a qualified researcher in the field of science or medicine, Tanabe Pharma Corporation will share clinical trial data that was collected from individual patients in a clinical trial with that researcher after a review committee of experts determines that such sharing is appropriate. Access Criteria: Please refer to the following link for conditions and limitations for sharing data. URL: https://www.tanabe-pharma.com/en/develop/protocol.html

Related trials for Diffuse Large B-Cell Lymphoma

Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
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Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Tanabe Pharma Corporation

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MT-2111 in people with Diffuse Large B-Cell Lymphoma, run by Tanabe Pharma Corporation at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) by independent central review (time frame: From the date of the first dose of treatment until the date of discontinuation or completion of the study (Up to 48 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05658562.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.