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Relapsed or Refractory B Cell Non-Hodgkin LymphomaPhase 1NCT05784441

A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

A Phase 1 study testing JNJ-90009530 in people with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, run by Janssen Research & Development, LLC at 15 sites in 4 countries.

Active, not recruiting

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

Official record
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Trial summary

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are: can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients. will JNJ-90009530 help patients achieve a response and for how long? Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
JNJ-90009530
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
15 sitesin 4 countries
Study dates
6 Nov 2023to 3 Jan 2040
Phase
Phase 1
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
  • All participants must have relapsed or refractory disease for each histologic subtype
  • Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 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). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
  • Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
  • Tumor must be cluster of differentiation (CD) 20 positive
  • Measurable disease as defined by Lugano 2014 classification
  • Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

Who cannot join

  • Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
  • Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
  • 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
Show all 10Show fewer
  • 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
  • Active central nervous system (CNS) involvement by malignancy
  • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States7 sites

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospital

    Iowa City, Iowa, 52242

  • University of Kentucky

    Lexington, Kentucky, 40506

  • Rutgers University

    New Brunswick, New Jersey, 08901

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

Other trials in United States

Australia5 sites

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Monash Medical Centre

    Clayton, 3168

  • Austin Hospital

    Heidelberg, 3084

  • Royal Brisbane and Women's Hospital

    Herston, 4029

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Israel2 sites

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 5266202

Other trials in Israel

United Kingdom1 site

  • University College London Hospitals

    London, NW1 2BU

Other trials in United Kingdom

About this study

Official title: A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:

  • can a dose of JNJ-90009530 be determined that is safe and well tolerated by patients.
  • will JNJ-90009530 help patients achieve a response and for how long?
Being tested
JNJ-90009530
Medical subject headings
Recurrence, Lymphoma, B-Cell

What participants receive

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

  • JNJ-90009530Drug

    Also called C-CAR066

    JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20

Study groups in NCT05784441
Study groupRoleWhat they receive
JNJ-90009530ExperimentalNot described
Receives: Drug: JNJ-90009530

What is being measured

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

  1. Calculate the Occurence of Adverse Events

    The safety and tolerability will be measured by recording the occurence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0

    Measured: up to 24 months

  2. Determine Recommended Phase 2 dose (RP2D)

    Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities

    Measured: up to 24 months

Secondary outcomes (4)

  1. Determine the Overall Response (OR)

    Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014

    Measured: up to 24 months

  2. Determine the time to response (TTR)

    Record the number of days from the date of JNJ-90009530 infusion to a CR or PR

    Measured: up to 24 months

  3. Determine the duration of response (DOR)

    Record the number of days from the date of the first CR or PR to relapse or death.

    Measured: up to 24 months

  4. Measure the amount of JNJ-90009530 in blood over time

    Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).

    Measured: up to 24 months

Timeline

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

  1. First posted24 Mar 2023
  2. Study start6 Nov 2023
  3. Primary completion6 Jan 2027 (estimated)
  4. Study completion3 Jan 2040 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784441
Sponsor's protocol ID
90009530LYM1001
Other IDs
90009530LYM1001, 2023-506259-97-00, 2023
Status last verified
Nov 2026
First submitted
3 Mar 2023
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 study testing JNJ-90009530 in people with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, run by Janssen Research & Development, LLC at 15 sites in 4 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 7 inclusion and 10 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 15 sites in United States, Australia, Israel, United Kingdom. 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 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.

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?

Calculate the Occurence of Adverse Events (time frame: up to 24 months). 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 NCT05784441.

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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