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Lymphoma, Non-HodgkinPhase 1/2NCT05421663

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

A Phase 1/2 study testing JNJ-90014496 in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Janssen Research & Development, LLC at 32 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-90014496
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
32 sitesin 8 countries
Study dates
12 Aug 2022to 30 Jul 2041
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

32 sites in 8 countries.

32 sites in 8 countries

United States14 sites

  • St. David's South Austin Medical Center

    Austin, Texas, 78704

  • Levine Cancer Institute

    Charlotte, North Carolina, 28001

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Greco Hainesworth Tennessee Oncology Centers for Research

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    Piscataway, New Jersey, 08854

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Texas Transplant Institute

    San Antonio, Texas, 78229

  • Swedish Cancer Institute

    Seattle, Washington, 98104

Other trials in United States

Australia4 sites

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • The Alfred Hospital

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Calvary Mater Newcastle Hospital

    Waratah, 2298

Other trials in Australia

Spain4 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • ICO L'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08908

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

Other trials in Spain

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Denmark2 sites

  • Rigshospitalet

    Copenhagen, 2100

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Netherlands2 sites

  • Erasmus MC

    Rotterdam, 3015 GD

  • UMC Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

United Kingdom2 sites

  • University College London Hospitals

    London, NW1 2BU

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

Other trials in United Kingdom

Canada1 site

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G2M9

Other trials in Canada

About this study

Official title: 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

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).

Being tested
JNJ-90014496
Keywords
CD20/CD19
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-90014496Biological

    JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.

Study groups in NCT05421663
Study groupRoleWhat they receive
JNJ-90014496ExperimentalParticipants will receive intravenous (IV) infusion of autologous JNJ-90014496. The study is no longer enrolling.
Receives: Biological: JNJ-90014496

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]

    Occurrence of any AEs, including dose limiting toxicities (DLTs).

    Measured: Up to 15 Years post JNJ-90014496 infusion

  2. Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)

    Overall response is defined as a PR or CR at any point between the time of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

Secondary outcomes (12)

  1. Phase 1b: Overall Response (OR)

    Overall response is defined as a PR or CR at any point between the time of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  2. Phase 1b: Duration of Response (DOR)

    DOR is defined as the time from the first documented CR or PR after JNJ-90014496 infusion until PD or death, whichever occurs first (per Lugano 2014 guidelines).

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  3. Phase 1b: Pharmacokinetic Evaluation of JNJ-90014496

    JNJ-90014496 blood levels will be reported.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  4. Phase 2: Occurrence of Adverse Events (AEs) by Severity

    Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening ), Grade 5 (Death). Cytokine release syndrome (CRS), Immune effector cell-associated neurotoxicity syndrome (ICANS), and Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.

    Measured: Up to 15 Years post JNJ-90014496 infusion

  5. Phase 2: Complete Response (CR)

    A CR is defined as at any point between the date of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  6. Phase 2: Duration of Response (DOR)

    DOR is defined as the time from the first documented CR or PR after JNJ-90014496 infusion to relapse or death, whichever occurs first.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  7. Phase 2: Progression Free Survival (PFS)

    PFS is defined as the time from the date of JNJ-90014496 infusion to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  8. Phase 2: Overall Survival (OS)

    OS is defined as the time from the date of JNJ-90014496 infusion to the date of death due to any cause.

    Measured: Up to 15 Years post JNJ-90014496 infusion

  9. Phase 2: Maximum Observed Blood Concentration (Cmax) for JNJ-90014496

    Blood samples will be analyzed to report Cmax for JNJ-90014496.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  10. Phase 2: Time to Reach Maximum Observed Cmax (Tmax) for JNJ-90014496

    Blood samples will be analyzed to report Tmax for JNJ-90014496.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  11. Phase 2: Area Under the Blood Concentration Time Curve (AUC) for JNJ-90014496

    AUC for JNJ-90014496 will be reported.

    Measured: Up to 6 months post last participant's JNJ-90014496 infusion

  12. Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score

    The FACT-Lym was developed for adult patients with lymphoma. The FACT Lym is self-administered, with a recall period for all items being the past 7 days. Responses are rated on a 5-point Likert response scale ranging from 0 "not at all" to 4 "very much". Higher scores indicate fewer symptoms and better well-being.

    Measured: From Baseline Up to 6 months post JNJ-90014496 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start12 Aug 2022
  3. Primary completion30 Jul 2041 (estimated)
  4. Study completion30 Jul 2041 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05421663
Sponsor's protocol ID
90014496LYM1001
Other IDs
2023-506267-33-00, 2023
Status last verified
Nov 2026
First submitted
10 Jun 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JNJ-90014496 in people with Lymphoma, Non-Hodgkin and Lymphoma, B-Cell, run by Janssen Research & Development, LLC at 32 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States, Australia, Spain, South Korea, Denmark and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability] (time frame: Up to 15 Years post JNJ-90014496 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05421663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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