NCT05784441

Brief 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?

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
166mo left

Started Nov 2023

Longer than P75 for phase_1

Geographic Reach
4 countries

15 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Nov 2023Jan 2040

First Submitted

Initial submission to the registry

March 3, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2027

Expected
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2040

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

March 3, 2023

Last Update Submit

May 7, 2026

Conditions

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

    up to 24 months

  • 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

    up to 24 months

Secondary Outcomes (4)

  • Determine the Overall Response (OR)

    up to 24 months

  • Determine the time to response (TTR)

    up to 24 months

  • Determine the duration of response (DOR)

    up to 24 months

  • Measure the amount of JNJ-90009530 in blood over time

    up to 24 months

Study Arms (1)

JNJ-90009530

EXPERIMENTAL
Drug: JNJ-90009530

Interventions

JNJ-90009530DRUG

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

Also known as: C-CAR066
JNJ-90009530

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Royal Prince Alfred Hospital

Camperdown, 2050, Australia

Location

Monash Medical Centre

Clayton, 3168, Australia

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Royal Brisbane and Women's Hospital

Herston, 4029, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Sheba Medical Center

Ramat Gan, 5266202, Israel

Location

University College London Hospitals

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

RecurrenceLymphoma, B-Cell

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 24, 2023

Study Start

November 6, 2023

Primary Completion (Estimated)

January 6, 2027

Study Completion (Estimated)

January 3, 2040

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

More information

Locations

IL(2)US(7)GB(1)AU(5)