Testing a new treatment for relapsed B-cell lymphoma
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
This study is testing a new combination treatment for people with relapsed B-cell lymphoma to see if it is safe and effective after they have tried other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 11 sites (Concord and 10 other locations) |
| Trial ID | NCT06660563 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of JNJ-80948543 in combination with another treatment, JNJ-75348780, for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study is divided into two parts: the first part focuses on determining the optimal dosage, while the second part assesses the safety of the recommended dosage. Participants must have previously undergone at least two lines of therapy and have measurable disease. The goal is to establish a recommended phase 2 regimen for further testing.
Who should consider this trial
Good fit: Ideal candidates are adults with diffuse large B-cell lymphoma who have received at least two prior lines of therapy and have measurable disease.
Not a fit: Patients with known active central nervous system involvement or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell lymphoma.
How similar studies have performed: Other studies involving CD3 T-cell engagers have shown promise, suggesting potential for success in this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Concord and 10 other locations
- Concord Hospital — Concord, Australia (Recruiting)
- St Vincents Hospital Melbourne — Fitzroy, Australia (Recruiting)
- Macquarie University Hospital — North Ryde, Australia (Recruiting)
- Hosp Univ Vall D Hebron — Barcelona, Spain (Recruiting)
- Hosp. Clinic de Barcelona — Barcelona, Spain (Recruiting)
- Inst. Cat. Doncologia-H Duran I Reynals — L Hospitalet De Llobregat, Spain (Recruiting)
- Hosp. Gral. Univ. Gregorio Maranon — Madrid, Spain (Recruiting)
- Hosp. Univ. 12 de Octubre — Madrid, Spain (Recruiting)
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei City, Taiwan (Recruiting)
- University Hospitals Of Leicester Nhs Trust — Leicester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.