A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Last updated: April 25, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Leukemia

Chronic Lymphocytic Leukemia

Treatment

JNJ-80948543

Clinical Study ID

NCT05424822
CR109174
2022-000685-18
80948543LYM1001
2023-504187-42-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chroniclymphocytic 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 intervalscorrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480milliseconds 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 sensitiveserum pregnancy test (beta- human chorionic gonadotropin) at screening and mustagree to further serum or urine pregnancy tests prior to the first dose, during thestudy and until 3 months after the last dose of study treatment

  • A female participant must agree not to be pregnant, breastfeeding, or planning tobecome pregnant while enrolled in this study or within 3 months after the last doseof study treatment

Exclusion

Exclusion Criteria:

  • Known active central nervous system (CNS) involvement; Lymphoma with CNS involvementmay be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts ifapproved by the study evaluation team (SET)

  • Prior solid-organ transplantation

  • Autoimmune or inflammatory disease requiring systemic steroids or otherimmunosuppressive agents (example, methotrexate or tacrolimus) within 1 year priorto first dose of study drug

  • Toxicity from prior anticancer therapy has not resolved to baseline levels or toGrade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathiesthat are stable on hormone replacement, which may be Grade 2)

  • Clinically significant pulmonary compromise, particularly the need for supplementaloxygen use to maintain adequate oxygenation

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: JNJ-80948543
Phase: 1
Study Start date:
August 18, 2022
Estimated Completion Date:
November 13, 2026

Connect with a study center

  • Macquarie University Hospital

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, 3004
    Australia

    Active - Recruiting

  • Linear Clinical Research Ltd

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Scientia Clinical Research

    Randwick, 2031
    Australia

    Active - Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400044
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060
    China

    Active - Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060
    China

    Active - Recruiting

  • Tianjin cancer hospital

    Tianjin, 300060
    China

    Active - Recruiting

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

    Wuhan, 430030
    China

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Rigshospitalet

    København, 2100
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 5000
    Denmark

    Active - Recruiting

  • CHRU de Lille - Hopital Claude Huriez

    Lille Cedex, 59037
    France

    Active - Recruiting

  • CHRU de Lille Hopital Claude Huriez

    Lille Cedex, 59037
    France

    Active - Recruiting

  • Hopital Saint Eloi

    Montpellier Cedex 5, 34285
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Active - Recruiting

  • Institut de Cancerologie Strasbourg Europe ICANS

    Strasbourg, 67033
    France

    Active - Recruiting

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse Cedex 9, 31059
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif, 94800
    France

    Site Not Available

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Active - Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577
    Japan

    Active - Recruiting

  • Aichi Cancer Center

    Nagoya Shi, 464 8681
    Japan

    Active - Recruiting

  • Aichi Cancer Center Hospital

    Nagoya Shi, 464 8681
    Japan

    Site Not Available

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550
    Japan

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

    Gdansk, 80 952
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Aidport Sp z o o

    Skorzewo, 60-185
    Poland

    Active - Recruiting

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185
    Poland

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Completed

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Texas Transplant Institute

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Active - Recruiting

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