A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
• 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
Locations
Other Locations
Australia
Concord Hospital
RECRUITING
Concord
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Macquarie University Hospital
RECRUITING
North Ryde
Spain
Hosp Univ Vall D Hebron
RECRUITING
Barcelona
Hosp. Clinic de Barcelona
RECRUITING
Barcelona
Inst. Cat. Doncologia-H Duran I Reynals
RECRUITING
L'hospitalet De Llobregat
Hosp. Gral. Univ. Gregorio Maranon
RECRUITING
Madrid
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Taiwan
China Medical University Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
United Kingdom
University Hospitals Of Leicester Nhs Trust
RECRUITING
Leicester
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2024-10-22
Estimated Completion Date:2026-09-21
Participants
Target number of participants:40
Treatments
Experimental: 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.