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

NCT05658562 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: MT-2111-A-101jRCT2021220031
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 23

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) by independent central review

  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)

  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)

  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)

  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)

  The time from the date of first dose until PD or death (Up to 48 months)

• Relapse-free survival (RFS)

  The time from the date of first observation of CR until PD or death in patients with CR observed (Up to 48 months)

Study Arms (1)

MT-2111 dosing regimen

EXPERIMENTAL

Drug: MT-2111

Interventions

MT-2111 DRUG

i.v. infusion

Also known as: Loncastuximab tesirine

MT-2111 dosing regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (23)

Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Kyushu Cancer Center

Fukuoka, Fukuoka, 811-1395, Japan

Location

Aso Iizuka Hospital

Iizuka-shi, Fukuoka, 820-8505, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu Municipal Hospital

Gifu, Gifu, 500-8513, Japan

Location

Gunma Prefectural Cancer Center

Ota-shi, Gunma, 373-8550, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyōgo, 670-8540, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Shinshu University Hospital

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Japanese Red Cross Nagasaki Genbaku Hospital

Nagasaki, Nagasaki, 852-8104, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, 530-0012, Japan

Location

Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

Osaka, Osaka, 530-0025, Japan

Location

Shimane University Hospital

Izumo-shi, Shimane, 693-8501, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, 113-8677, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-0063, Japan

Location

Disaster Medical Center

Tachikawa-shi, Tokyo, 190-0014, Japan

Location

Yamagata University Hospital

Yamagata, Yamagata, 990-9585, Japan

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

loncastuximab tesirine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 20, 2022
• Study Start: January 30, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (23)