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NCT05424822 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 1
- Development phase
- 167
- Enrollment target
- 20
- Study locations
NCT05424822: Active Phase 1 study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, sponsored by Janssen Research & Development.
NCT05424822 is a Phase 1 study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 167 participants, below the 386-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05424822, a Phase 1 study of Lymphoma, Non-Hodgkin and Leukemia, Lymphocytic, Chronic, B-Cell, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 167 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG JNJ-80948543
Study Locations (20)
Other
- Macquarie University Hospital - Macquarie University
- The Alfred Hospital - Melbourne
- Linear Clinical Research Ltd - Nedlands
- Scientia Clinical Research - Randwick
- Chongqing University Cancer Hospital - Chongqing
- Sun Yat Sen University Cancer Center - Guangzhou
- Tianjin cancer hospital - Tianjin
- Union Hospital Tongji Medical College of Huazhong University of Science and Technology - Wuhan
- Rigshospitalet - Copenhagen
- Odense University Hospital - Odense
- CHRU de Lille Hopital Claude Huriez - Lille
- Institut Curie - Paris
- Institut de Cancerologie Strasbourg Europe ICANS - Strasbourg
New York
- Icahn School of Medicine at Mount Sinai - New York
- Memorial Sloan Kettering Cancer Center - New York
Texas
- The University of Texas MD Anderson Cancer Center - Houston
- Texas Transplant Institute - San Antonio
California
- City of Hope - Duarte
Tennessee
- Sarah Cannon Research Institute - Nashville
Washington
- Seattle Cancer Care Alliance - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2022-08-18 |
| Est. Completion | 2027-07-30 |
| Phase | Phase 1 |
What the registry record for NCT05424822 still lists
NCT05424822 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 386-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with Lymphoma, Non-Hodgkin appearing as the primary indexed condition, and to 1 intervention - of which JNJ-80948543 is the first listed.
NCT05424822 names 20 study sites across 6 states, led by Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT05424822 about?
NCT05424822 is a clinical study titled "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)". 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...
What is the current status of trial NCT05424822?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 167 participants. The study started on 2022-08-18. Estimated completion is 2027-07-30.
What conditions does trial NCT05424822 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell.
What interventions are being tested in trial NCT05424822?
The interventions under investigation include: JNJ-80948543 (DRUG).
Who is sponsoring clinical trial NCT05424822?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05424822 being conducted?
This trial has 20 study locations across California, New York, Tennessee, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05424822's enrollment target sits among peer trials
167 21st of 58 higher than 38 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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