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)
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-80948543: JNJ-80948543 will be administered as SC or IV injection.
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
Primary outcome measure(s)
- Number of Participants with Dose-limiting Toxicity (DLT) — Up to 4 Years 3 months
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. - Number of Participants with Adverse Events (AEs) — Up to 4 Years 3 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. - Number of Participants with AE by Severity — Up to 4 Years 3 months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 4 (Life-threatening). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded as per American Society for Transplantation and Cellular Therapy (ASTCT).
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Texas Transplant Institute | San Antonio | Texas | |
| Seattle Cancer Care Alliance | Seattle | Washington | |
| 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 |
More Janssen Research & Development, LLC trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05424822 on ClinicalTrials.gov ↗ ← All trials in France