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New combo therapy targets tough lymphoma in early trial

NCT ID NCT06139406

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug (JNJ-87801493) combined with immune-activating therapies (T-cell engagers) in about 70 people whose B-cell non-Hodgkin lymphoma has returned or stopped responding to other treatments. The main goals are to check safety and find the best dose. The trial is not yet recruiting and is actively ongoing.

What this could mean

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

Active substance
JNJ-87801493 combined with T-cell engagers (JNJ-80948543 or JNJ-75348780)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat B-cell non-Hodgkin lymphoma.
What could go wrong
This is a very early (Phase 1) and small (70 participants) trial focused on safety, not yet on effectiveness. The combination may cause serious side effects like cytokine release syndrome, and it may not work for many patients.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

70 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Sep 2026

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: * Histologic documentation of B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included * Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug * Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study. Exclusion Criteria: * Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET) * Prior solid-organ transplantation * Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients * Chemotherapy, targeted therapy, or immunotherapy within 2 weeks before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 \[anti-PD-1\]), a washout period of up to 6 weeks may be considered * Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor * Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment * Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment * Abnormal cardiac function

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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

  • Austin Hospital

    Heidelberg, 3084, Australia

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Linear Clinical Research Ltd

    Nedlands, 6009, Australia

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, DK-2100, Denmark

  • Scientia Clinical Research

    Randwick, 2031, Australia

  • Sourasky (Ichilov) Medical Center

    Tel Aviv, 6423906, Israel

  • The Alfred Hospital

    Melbourne, 3004, Australia

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