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New antibody drug shows promise in early blood cancer trial

NCT ID NCT04540796

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called JNJ-75348780 in 147 people with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia. The drug is a bispecific antibody designed to help the immune system attack cancer cells. The main goals were to check safety and find the right dose for future studies.

What this could mean

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

Active substance
JNJ-75348780 (a bispecific antibody that targets CD3 and CD22 proteins on immune and cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is not yet known if the drug works. Side effects, including immune reactions, are possible.

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

147 people

The number who actually took part.

Started

Nov 2020

Finished

Sep 2025

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 NHL or 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 a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue \[MALT\]), or Waldenstrom macroglobulinemia (WM): previously treated with a minimum of 2 prior lines of systemic therapy, with at least 1 prior line containing an anti-CD20 antibody, c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 2 prior lines of therapy to include a bruton tyrosine kinase inhibitor (BTKi) and/or a B-cell lymphoma (BCL)2 inhibitor, if eligible. 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 (ms) based on the average of triplicate assessments performed no more than 5 (plus minus \[+ -\] 3) minutes apart * Women of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug * Women must be: a) not of childbearing potential, b) of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of less than (\<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 90 days after last dose Exclusion Criteria: * Known central nervous system (CNS) involvement with lymphoma * Prior solid-organ transplantation * Either of the following: a) received an autologous stem cell transplant \<=3 months before the first dose of JNJ 75348780, b) prior treatment with allogenic stem cell transplant \<= 6 months before the first dose of JNJ-75348780, or has evidence of graft versus host disease that requires immunosuppressant therapy * Prior chemotherapy, targeted therapy, immunotherapy or radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), within 2 weeks before the first administration of study drug. 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, whichever is longer. For investigational agents with long half-lives a wash-out of 4 weeks is acceptable. Participants who received prior treatment with anti-CD20 \* anti-CD3 bispecific therapy will be excluded until a dedicated cohort(s) is opened as determined by the SET * Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus) * History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 1 year before the first dose of study drug. Concomitant malignancies that are unlikely to progress and/or preclude evaluation of study endpoints may be allowed after discussion with the Study Responsible Physician

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma lymphoma, non-Hodgkin, familial mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma Waldenstrom macroglobulinemia

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

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital

    Heidelberg, 3084, Australia

  • CHRU de Lille Hopital Claude Huriez

    Lille, 59037, France

  • CHU Nantes

    Nantes, 44093, France

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Chang-Gung Memorial Hospital, Kaohsiung

    Kaohsiung City, 83301, Taiwan

  • China Medical University Hospital

    Taichung, 40402, Taiwan

  • 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. Germans Trias I Pujol

    Barcelona, 8916, Spain

  • Hospital de Vall D'Hebron

    Barcelona, 08035, Spain

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Leicester Royal Infirmary

    Leicester, LE1 5WW, United Kingdom

  • Linear Clinical Research Ltd

    Nedlands, 6009, Australia

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Plymouth Hospital NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • Rambam Medical Center

    Haifa, 31096, Israel

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba Medical Center

    Ramat Gan, 74047, Israel

  • Taichung Veterans General Hospital

    Taichung, 40705, Taiwan

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906, Israel

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

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