A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
- Conditions
- Lymphoma, Non-HodgkinLymphoma, B-Cell
- Interventions
- Biological: JNJ-90014496
- Registration Number
- NCT05421663
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief Summary
This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with B-Cell non-Hodgkin lymphoma (B-NHL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 230
- Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
- Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
- Must meet the following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have had >= 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); Relapsed or refractory follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had >= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
- Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL
- Measurable disease as defined by Lugano 2014 classification
- Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort
- Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma
- Any prior solid organ or allogeneic stem cell transplantation
- 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
- Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JNJ-90014496 JNJ-90014496 Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.
- Primary Outcome Measures
Name Time Method Occurrence of Adverse Events (AEs) [Safety and Tolerability] Up to 24 months Occurrence of any AEs, including dose limiting toxicities (DLTs).
Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with B-cell non-Hodgkin lymphoma (B-NHL) Up to 24 months Based on the assessment of DLTs rates and overall safety profile.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Evaluation of JNJ-90014496 Up to 24 months JNJ-90014496 blood levels will be reported.
Time to Response (TTR) Up to 24 months The time from the date of JNJ-90014496 infusion to the first documented CR or PR will be assessed by Lugano 2014 guidelines.
Overall Response (OR) Up to 24 months Complete response (CR) and partial response (PR) will be assessed by Lugano 2014 guidelines.
Duration of Response (DOR) Up to 24 months The time from the first documented CR or PR to relapse or death, whichever occurs first will be assessed by Lugano 2014 guidelines.
Trial Locations
- Locations (26)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
City of Hope
🇺🇸Duarte, California, United States
Rutgers Cancer Institute of New Jersey
🇺🇸Piscataway, New Jersey, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
The Alfred Hospital
🇦🇺Melbourne, Australia
Levine Cancer Institute
🇺🇸Charlotte, North Carolina, United States
St Vincents Hospital Melbourne
🇦🇺Fitzroy, Australia
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
St. David's South Austin Medical Center
🇺🇸Austin, Texas, United States
Texas Transplant Institute
🇺🇸San Antonio, Texas, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, Australia
Princess Margaret Cancer Centre University Health Network
🇨🇦Toronto, Ontario, Canada
Rigshospitalet
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
UMC Utrecht
🇳🇱Utrecht, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
Hosp Univ Vall D Hebron
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
🇪🇸Madrid, Spain
University College London Hospitals
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
🇬🇧Manchester, United Kingdom