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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05784441




Registration number
NCT05784441
Ethics application status
Date submitted
3/03/2023
Date registered
24/03/2023
Date last updated
9/10/2024

Titles & IDs
Public title
A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)
Scientific 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
Secondary ID [1] 0 0
2023-506259-97-00
Secondary ID [2] 0 0
90009530LYM1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JNJ-90009530

Experimental: JNJ-90009530 -


Treatment: Drugs: JNJ-90009530
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Calculate the Occurence of Adverse Events
Timepoint [1] 0 0
up to 24 months
Primary outcome [2] 0 0
Determine Recommended Phase 2 dose (RP2D)
Timepoint [2] 0 0
up to 24 months
Secondary outcome [1] 0 0
Determine the Overall Response (OR)
Timepoint [1] 0 0
up to 24 months
Secondary outcome [2] 0 0
Determine the time to response (TTR)
Timepoint [2] 0 0
up to 24 months
Secondary outcome [3] 0 0
Determine the duration of response (DOR)
Timepoint [3] 0 0
up to 24 months
Secondary outcome [4] 0 0
Measure the amount of JNJ-90009530 in blood over time
Timepoint [4] 0 0
up to 24 months

Eligibility
Key inclusion criteria
Key Inclusion Criteria

* 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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* 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, cerebrovascular ischemia/hemorrhage, 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Israel
State/province [8] 0 0
Jerusalem
Country [9] 0 0
Israel
State/province [9] 0 0
Ramat Gan
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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 safe 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 website
https://clinicaltrials.gov/study/NCT05784441
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05784441