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New antibody therapy targets blood cancers in early trial

NCT ID NCT05424822

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug called JNJ-80948543 in people with non-Hodgkin lymphoma or chronic lymphocytic leukemia whose cancer has returned or not responded to other treatments. The drug works by redirecting the body's T-cells to attack cancer cells. The main goals are to check safety and find the best dose. About 167 participants will take part.

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

167 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Jul 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

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 disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy. All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met: If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment. If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody. If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines . Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy. small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria * Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1 * Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula \[QTcF\]) less than or equal to (\<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus \[+-\] 3) minutes apart * A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment * A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment Exclusion Criteria: * Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET) * Prior solid-organ transplantation * Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug * Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2) * Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell non-Hodgkin lymphoma lymphoma, non-Hodgkin, familial non-Hodgkin lymphoma

As listed by the trial registrant

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

Leukemia, lymphocytic, chronic, B-cell Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, 464 8681, Japan

  • Aidport Sp z o o

    Skorzewo, 60-185, Poland

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037, France

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Chongqing University Cancer Hospital

    Chongqing, 400044, China

  • City of Hope

    Duarte, California, 91010, United States

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Institut Curie

    Paris, 75005, France

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059, France

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67033, France

  • Linear Clinical Research Ltd

    Nedlands, 6009, Australia

  • Macquarie University Hospital

    Macquarie University, 2109, Australia

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • National Cancer Center Hospital East

    Kashiwa, 277 8577, Japan

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Scientia Clinical Research

    Randwick, 2031, Australia

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060, China

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Transplant Institute

    San Antonio, Texas, 78229, United States

  • The Alfred Hospital

    Melbourne, 3004, Australia

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Tianjin cancer hospital

    Tianjin, 300060, China

  • Union Hospital Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

    Gdansk, 80 214, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.