Relapsed/refractory B-cell non-Hodgkin lymphoid malignancies Cancer
Conditions
Interventions
JNJ-75348780 will be administered as a subcutaneous (SC) injection and JNJ-80948543 will be administered as a subcutaneous (SC) or an intravenous (IV) injection.
Participants will receive JNJ-8094854
Sponsors
Janssen Research & Development, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. 2. All participants must have received at least 2 prior lines of therapy 3. Participants must have measurable disease as defined by the appropriate disease response criteria 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 5. Hematologic laboratory parameters must meet the required criteria's and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of the study drug 6. Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (ß)-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
Exclusion criteria
Exclusion criteria: 1. Known active central nervous system involvement (CNS) or leptomeningeal involvement 2. Prior solid-organ transplantation 3. Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (for example, methotrexate or tacrolimus) within 1 year before the first dose of the 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 defined as the need for supplemental oxygen to maintain adequate oxygenation 6. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with dose-limiting toxicity (DLT) will be reported up to 1 year and 10 months. 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). 2. Number of participants with adverse events (AEs) will be reported 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
| Measure | Time frame |
|---|---|
| 1. Serum concentration-time profiles and PK parameters for JNJ-8094853 and JNJ-75348780 will be reported up to 1 year and 10 months and will be measured and reported as descriptive statistics using available serum concentrations. 1.1. Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780 will be assessed up to 1 year and 10 months and will be measured and reported as descriptive statistics using available serum concentrations. Tmax is the time to reach the maximum observed serum concentration for JNJ-80948543 and JNJ-75348780. 1.2. Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780 will be reported up to 1 year and 10 months and will be measured and reported as descriptive statistics using available serum concentrations. 1.3. Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780 will be assessed up to 1 year and 10 months and will be measured and reported as descriptive statistics using available serum concentrations. 2. The number of participants with the presence of anti-JNJ-80948543 and anti-JNJ-75348780 antibodies assessed up to 1 year and 10 months and will be measured and reported as descriptive statistics using available serum concentrations. 3. Overall Response Rate (ORR), Complete Response Rate (CRR) and Duration of Response (DoR), where the response will be assessed by the investigator based on standard response criteria up to 1 year and 10 months. | — |
Countries
Australia, England, Spain, Taiwan, United Kingdom
Outcome results
None listed