ACTIVE_NOT_RECRUITING

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)

Talk to us

Conditions

Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1, First-in-human Study of JNJ-80948543, a T-cell Redirecting Antibody, in Participants With NHL and CLL

Quick Facts

Study Start:2022-08-18
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05424822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
  3. * 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
  4. * 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
  5. * 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
  1. * Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
  2. * Prior solid-organ transplantation
  3. * 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
  4. * 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)
  5. * Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial
STUDY_DIRECTOR
Janssen Research & Development, LLC

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Texas Transplant Institute
San Antonio, Texas, 78229
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

  • Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-18
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2022-08-18
Study Completion Date2027-07-30

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell