Testing JNJ-90009530 for patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
PHASE1 · Janssen Research & Development, LLC · NCT05784441
This study is testing a new drug called JNJ-90009530 to see if it can help people with relapsed or hard-to-treat B-Cell Non-Hodgkin Lymphoma feel better.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC (industry) |
| Drugs / interventions | chimeric antigen receptor, chemotherapy |
| Locations | 15 sites (Iowa City, Iowa and 14 other locations) |
| Trial ID | NCT05784441 on ClinicalTrials.gov |
What this trial studies
This multicenter clinical trial aims to evaluate the safety and efficacy of JNJ-90009530 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma. The study will determine a safe dosage of the drug and assess its effectiveness in achieving a response in patients. Participants must have previously undergone multiple lines of systemic therapy and have measurable disease. The trial will focus on various histologic subtypes of B-NHL, ensuring a comprehensive approach to treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-Cell Non-Hodgkin Lymphoma who have received prior systemic therapies.
Not a fit: Patients with non-relapsed B-Cell Non-Hodgkin Lymphoma or those who have not received prior systemic therapy 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 Non-Hodgkin Lymphoma.
How similar studies have performed: Other studies have shown promise with similar therapeutic approaches in treating B-Cell Non-Hodgkin Lymphoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria * Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent * All participants must have relapsed or refractory disease for each histologic subtype * Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have \>= 2 lines of systemic therapy or \>=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent * Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have \>=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody * Tumor must be cluster of differentiation (CD) 20 positive * Measurable disease as defined by Lugano 2014 classification * Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 Key Exclusion Criteria * Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL) * Prior allogeneic Hematopoietic stem cell transplantation (HSCT) * Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion * Uncontrolled active infections * History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis \[DVT\]) * History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association \[NYHA\] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening * History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder * Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system * Active central nervous system (CNS) involvement by malignancy * Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Where this trial is running
Iowa City, Iowa and 14 other locations
- University of Iowa Hospital — Iowa City, Iowa, United States (RECRUITING)
- University of Kentucky — Lexington, Kentucky, United States (RECRUITING)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (RECRUITING)
- Rutgers University — New Brunswick, New Jersey, United States (RECRUITING)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Royal Prince Alfred Hospital — Camperdown, Australia (RECRUITING)
- Monash Medical Centre — Clayton, Australia (RECRUITING)
- Austin Hospital — Heidelberg, Australia (RECRUITING)
- Royal Brisbane and Women's Hospital — Herston, Australia (RECRUITING)
- Westmead Hospital — Westmead, Australia (RECRUITING)
- Hadassah Medical Center — Jerusalem, Israel (RECRUITING)
- Sheba Medical Center — Ramat Gan, Israel (RECRUITING)
- University College London Hospitals — London, 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.
Conditions: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma