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New shot shows promise against tough lymphoma in japanese study

NCT ID NCT04542824

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This trial tests a drug called epcoritamab in about 78 Japanese adults with B-cell lymphoma that has returned or not improved after standard treatment. The study has two parts: first, finding a safe dose, and then checking how well the drug works alone or with other chemotherapy. The goal is to see if this immune-boosting shot can help control the cancer.

What this could mean

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

Active substance
Epcoritamab (also called EPKINLY™) is a drug given as a shot under the skin. It helps the immune system attack cancer cells.
What this could lead to
If this trial works, it could offer a new treatment option for Japanese patients with B-cell lymphoma that has come back or not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of patients, so results may not apply to everyone. Side effects are possible, and the drug may not work as hoped.

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

78 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Sep 2027

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

20 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.

Main Inclusion Criteria: • Must be at least 20 years of age, inclusive • Japanese participants • CD20 positivity at representative tumor biopsy 1. Part 1: * Diffuse large B-cell lymphoma (de novo or histologically transformed) * High-grade B-cell lymphoma * Primary mediastinal large B-cell lymphoma * Follicular lymphoma * Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic) * Small lymphocytic lymphoma 2. Part 2 : Arm 1: * Diffuse large B-cell lymphoma (de novo or histologically transformed) * Follicular lymphoma grade 1-3A * Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 monoclonal antibody (mAb)-containing therapy. * Measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET)-CT scan Arm 2: • R/R FL grade 1, 2 or 3a, stage II, III, or IV, without evidence of transformation. * Previously treated with at least 1 prior anti-neoplastic agent, including anti-CD20 antibody * Must have a need for treatment initiation based on symptoms and/or disease burden (Groupe d'Etude des Lymphomes Folliculaires \[GELF\] criteria) * Eligible to receive R2 per investigator determination Arm 3: * One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) : o DLBCL, not otherwise specified (NOS) * "Double-hit" or "triple-hit" DLBCL * FL Grade 3B. * T-cell/histiocyte rich large B-cell lymphoma (LBCL) * International Prognostic Index (IPI) score ≥3 * No prior therapy for DLBCL or FL grade 3B (G3B) other than nodal biopsy, corticosteroids, or palliative radiotherapy. * Eligible to receive R-CHOP per investigator determination Arm 4: * One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) including: o DLBCL, NOS. o "Double-hit" or "triple-hit" DLBCL * FL Grade 3B. * T-cell/histiocyte rich LBCL * Relapsed or refractory to at least one prior therapy including at least one prior anti-CD20 antibody. * Either failed prior autologous hematopoietic stem cell transplantation (ASCT), or ineligible for autologous hematopoietic stem-cell transplantation (HSCT) * Eligible to receive GemOx per investigator determination Arm 5: • History of histologically confirmed CD20+ FL Grade 1-3a without evidence of transformation. • In CR or PR per Lugano criteria following first-line or second-line treatment with SOC regimen, including anti-CD20 antibody, and last dose of SOC within 6 months prior to enrollment Main Exclusion Criteria: • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening • Participants not eligible for high dose therapy with autologous hematopoietic stem cell transplantation due to personal choice, social issues, or similar • Known clinically significant cardiac disease • Chronic ongoing infectious diseases requiring treatment (excluding prophylactic treatment) Exclusion criteria for Part 2, Arms 2 through 5: Arm 2: • FL Grade 3b • Histologic evidence of transformation to an aggressive lymphoma * Contraindication to rituximab or lenalidomide * Unwilling or unable to take aspirin prophylaxis or prophylactic anticoagulant as clinically indicated Arm 3: • Contraindication to any of the individual drugs of the R-CHOP regimen Arm 4: * Contraindication to any of the individual drugs of the GemOx regimen Arm 5: * FL Grade 3b * Histologic evidence of transformation to an aggressive lymphoma

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Aichi, Japan

  • Cancer Institute Hospital of JFCR

    Tokyo, Japan

  • Fukushima Medical University Hospital

    Fukushima, Japan

  • Kagoshima University Hospital

    Kagoshima, Japan

  • Kindai University Hospital

    Osaka, Japan

  • Kyoto University Hospital

    Kyoto, Japan

  • Matsuyama Red Cross Hospital

    Ehime, Japan

  • NHO Nagoya Medical Center

    Aichi, Japan

  • National Cancer Center Hospital

    Tokyo, Japan

  • National Cancer Center Hospital East

    Chiba, Japan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Japan

  • Osaka University Hospital

    Osaka, Japan

  • Tohoku University Hoaspital

    Sendai, Miyagi, 980-8577, Japan

  • Tokyo Medical University Hospital

    Tokyo, Japan

  • Yamagata University Hospital

    Yamagata, Japan

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