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Treatment for B-Cell Non-Hodgkin Lymphoma using CAR-T Cells

A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma

Phase1; Phase2 Interventional Janssen Research & Development, LLC · NCT05421663

This study is testing a new CAR-T cell therapy for adults with B-Cell non-Hodgkin lymphoma to see if it can help those whose cancer has come back or hasn't responded to other treatments.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment439 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations32 sites (Duarte, California and 31 other locations)
Trial IDNCT05421663 on ClinicalTrials.gov

What this trial studies

This Phase Ib multicenter, open-label study evaluates JNJ-90014496, an autologous bi-specific CAR T-cell therapy that targets both CD19 and CD20, in adult patients with B-Cell non-Hodgkin lymphoma. Participants must have histologically confirmed CD19 and/or CD20 positive tumors and have undergone multiple lines of prior systemic therapy. The study aims to assess the safety and efficacy of this innovative treatment approach for relapsed or refractory cases of B-NHL.

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 multiple lines of prior therapy.

Not a fit: Patients who have not had prior exposure to anti-CD20 monoclonal antibodies or those with tumors that are not CD19/CD20 positive 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 using CAR-T cell therapies targeting CD19 and CD20 have shown promising results, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 this trial is running

Duarte, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, Large B-Cell, DiffuseCD20/CD19
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.