Actively Recruiting
A Phase 1b/2, Multicenter, Open-label Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adults with B-cell Non-Hodgkin Lymphoma
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
439
Participants Needed
32
Research Sites
656 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating prizloncabtagene autoleucel (prizlo-cel), an autologous dual targeting CAR T-cell therapy that targets CD19 and CD20, for adults with relapsed or refractory B-cell non-Hodgkin lymphoma or frontline high-risk diffuse large B-cell lymphoma. This Phase 1b/2, multicenter, open-label study aims to assess safety, tolerability, and treatment response in this population. Participants will receive an intravenous infusion of prizlo-cel. The study includes two phases: Phase 1b focuses on safety and tolerability up to two years after infusion, while Phase 2 evaluates overall response assessed by an independent review committee, also up to two years post-infusion. The therapy is designed to target specific lymphoma cells using the patient’s own modified T cells. Throughout the study, participants will be monitored for adverse events and treatment responses for up to two years. Researchers will assess overall response, duration of response, progression-free survival, overall survival, and pharmacokinetics of the therapy. Patient quality of life will also be measured using symptom score questionnaires. Safety and effectiveness data will be collected and reviewed regularly during follow-up visits.
CONDITIONS
Brief Title
A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent
- Tumor must be histologically confirmed CD19 and/or CD20 positive
- Diagnosis of Large B-cell lymphoma, Follicular large B-cell lymphoma, or transformation of indolent lymphoma
- Received at least 2 prior lines of systemic therapy
- Relapsed or refractory disease as defined by stable or progressive disease after most recent therapy or progression after partial or complete response
- Measurable disease as defined by Lugano 2014 classification
- ECOG performance status of 0 to 2
You will not qualify if you...
- History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line-associated deep vein thrombosis allowed)
- History of stroke, unstable angina, myocardial infarction, congestive heart failure NYHA Class III or IV, severe cardiomyopathy, or ventricular arrhythmia requiring medication or mechanical control within 6 months of apheresis
- History of seizure disorder, dementia, cerebellar disease, or neurodegenerative disorder
- Known history or diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
- Current active liver or biliary disease (except Gilbert's syndrome or asymptomatic gallstones)
- Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy or uncontrolled systemic fungal infection
- Diagnosis of HHV 8-positive DLBCL, T cell/histiocyte-rich large B-cell lymphoma, Burkitt and high-grade B-cell lymphoma with 11q aberrations, Richter's transformation, Lymphomatoid granulomatosis, Plasmablastic lymphoma, or Waldenstrom's Macroglobulinemia
- Any prior solid organ or allogeneic stem cell transplantation
- Autologous stem cell transplant within 12 weeks of apheresis
- Prior CAR-T cell therapy within 12 weeks of apheresis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years post infusion
Participants receive an intravenous infusion of autologous Prizloncabtagene autoleucel (Prizlo-Cel), a dual targeting CAR-T cell therapy for B-cell Non-Hodgkin Lymphoma.
Visits occur for infusion and monitoring during treatment period
Duration - Up to 2 years post infusion
Participants are monitored for safety, response to treatment, and overall health for up to 2 years after receiving Prizlo-Cel infusion.
Regular visits for assessment and safety monitoring during follow-up period
Trial Site Locations
Total: 32 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
3
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
5
Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey, United States, 08854
Actively Recruiting
6
Levine Cancer Institute
Charlotte, North Carolina, United States, 28001
Actively Recruiting
7
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
8
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
9
Greco Hainesworth Tennessee Oncology Centers for Research
Nashville, Tennessee, United States, 37203
Actively Recruiting
10
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
11
St. David's South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
12
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Actively Recruiting
14
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
15
St Vincents Hospital Melbourne
Fitzroy, Australia, 3065
Actively Recruiting
16
The Alfred Hospital
Melbourne, Australia, 3004
Actively Recruiting
17
Fiona Stanley Hospital
Murdoch, Australia, 6150
Actively Recruiting
18
Calvary Mater Newcastle Hospital
Waratah, Australia, 2298
Completed
19
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada, M5G2M9
Active, Not Recruiting
20
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
21
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
22
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
23
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Actively Recruiting
24
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
25
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
26
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
27
Hosp Univ Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
28
Hosp Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
29
ICO L'Hospitalet - Hospital Duran i Reynals
Barcelona, Spain, 08908
Actively Recruiting
30
Hosp Univ Fund Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
31
University College London Hospitals
London, United Kingdom, NW1 2BU
Actively Recruiting
32
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
S
Study Contact, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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