A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

In brief

This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

Key facts

Study ID

NCT05421663

Run by

Janssen Research & Development, LLC

People needed

166

Starts

2022-08-12

Expected to finish

2041-07-30

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocol
• Measurable disease as defined by Lugano 2014 classification
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2

You may not qualify if…

• History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
• 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 apheresis
• 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)
• Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
• Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or 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

Where it is running

• City of Hope — Duarte, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Rutgers Cancer Institute of New Jersey — Piscataway, New Jersey, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Greco Hainesworth Tennessee Oncology Centers for Research — Nashville, Tennessee, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• St. David's South Austin Medical Center — Austin, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Transplant Institute — San Antonio, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• St Vincents Hospital Melbourne — Fitzroy, Australia
• The Alfred Hospital — Melbourne, Australia
• 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
• Erasmus MC — Rotterdam, Netherlands
• UMC Utrecht — Utrecht, Netherlands
• Seoul National University Hospital — Seoul, South Korea
• Asan Medical Center — Seoul, South Korea

Full record on ClinicalTrials.gov

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