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)
NCT ID: NCT05424822
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
167 participants
INTERVENTIONAL
2022-08-18
2027-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A: Dose Escalation
Participants will receive JNJ-80948543 either by subcutaneous (SC) or intravenous (IV) administration to determine the putative recommended Phase 2 dose (RP2D) dosing schedule(s) and route(s) of administration based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens.
JNJ-80948543
JNJ-80948543 will be administered as SC or IV injection.
Part B: Cohort Expansion
Participants will receive JNJ-80948543 by SC or IV administration.
JNJ-80948543
JNJ-80948543 will be administered as SC or IV injection.
Interventions
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JNJ-80948543
JNJ-80948543 will be administered as SC or IV injection.
Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Macquarie University Hospital
Macquarie University, , Australia
The Alfred Hospital
Melbourne, , Australia
Linear Clinical Research Ltd
Nedlands, , Australia
Scientia Clinical Research
Randwick, , Australia
Chongqing University Cancer Hospital
Chongqing, , China
Sun Yat Sen University Cancer Center
Guangzhou, , China
Tianjin cancer hospital
Tianjin, , China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
CHRU de Lille Hopital Claude Huriez
Lille, , France
Institut Curie
Paris, , France
Institut de Cancerologie Strasbourg Europe ICANS
Strasbourg, , France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, , France
Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
National Cancer Center Hospital East
Kashiwa, , Japan
Aichi Cancer Center
Nagoya, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk, , Poland
Aidport Sp z o o
Skorzewo, , Poland
Countries
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Other Identifiers
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2022-000685-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
80948543LYM1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504187-42-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109174
Identifier Type: -
Identifier Source: org_study_id