A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
NCT ID: NCT06660563
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
19 participants
INTERVENTIONAL
2024-10-22
2026-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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JNJ-80948543
Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780.
JNJ-80948543
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780
JNJ-75348780 will be administered as SC injection.
Interventions
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JNJ-80948543
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780
JNJ-75348780 will be administered as SC injection.
Eligibility Criteria
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Inclusion Criteria
* Participants must have measurable disease as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* 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 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
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 defined as the need for supplemental oxygen to maintain adequate oxygenation
* Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
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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Concord Hospital
Concord, , Australia
St Vincents Hospital Melbourne
Fitzroy, , Australia
Macquarie University Hospital
North Ryde, , Australia
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Clinic de Barcelona
Barcelona, , Spain
Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
University Hospitals Of Leicester Nhs Trust
Leicester, , United Kingdom
Countries
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Other Identifiers
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80948543LYM1002
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514176-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
80948543LYM1002
Identifier Type: -
Identifier Source: org_study_id