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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05421663




Registration number
NCT05421663
Ethics application status
Date submitted
10/06/2022
Date registered
16/06/2022

Titles & IDs
Public title
A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Scientific title
A Phase Ib Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
90014496LYM1001
Secondary ID [2] 0 0
90014496LYM1001
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: Other - JNJ-90014496

Experimental: JNJ-90014496 - Participants will receive intravenous (IV) infusion of autologous JNJ-90014496 on Day 1.


Treatment: Other: JNJ-90014496
JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)19 and CD20.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Adverse Events (AEs) [Safety and Tolerability]
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Response (OR)
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Time to Response (TTR)
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Pharmacokinetic Evaluation of JNJ-90014496
Timepoint [4] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
* Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
* Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular lymphoma
* Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
* Must have relapsed or refractory disease with the following indications for each histologic subtype: Mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy, or >= 1 line of systemic therapy for participants who are ineligible for autologous stem cell transplant; 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
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of either 0 or 1
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
* Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
12/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/10/2028
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 0 0
Calvary Mater Newcastle Hospital - Waratah
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
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
North Carolina
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
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
Denmark
State/province [10] 0 0
Odense
Country [11] 0 0
Netherlands
State/province [11] 0 0
Utrecht
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
United Kingdom
State/province [13] 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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John Baird, M.D.
Address 0 0
City of Hope Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact, M.D.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05421663