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)
- Registration Number
- NCT06660563
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- Known active central nervous system involvement (CNS) or leptomeningeal involvement
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description JNJ-80948543 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-75348780 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Dose-limiting Toxicity (DLT) Up to 1 year and 10 months Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia).
Number of Participants with Adverse Events (AEs) Up to 1 year and 10 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.
- Secondary Outcome Measures
Name Time Method Serum Concentration of JNJ-80948543 and JNJ-75348780 Up to 1 year and 10 months Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.
Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780 Up to 1 year and 10 months AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.
Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780 Up to 1 year and 10 months Cmax for JNJ-80948543 and JNJ-75348780 will be reported.
Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780 Up to 1 year and 10 months Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780.
Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780 Up to 1 year and 10 months Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed.
Overall Response Rate (ORR) Up to 1 year and 10 months ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria.
Complete Response Rate (CRR) Up to 1 year and 10 months CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria.
Duration of Response (DoR) Up to 1 year and 10 months DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria.
Trial Locations
- Locations (11)
Inst. Cat. Doncologia-H Duran I Reynals
🇪🇸L Hospitalet De Llobregat, Spain
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
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 City, Taiwan
University Hospitals Of Leicester Nhs Trust
🇬🇧Leicester, United Kingdom