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| ID | Type | Description | Link |
|---|---|---|---|
| 90009530LYM1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-506259-97-00 | Registry Identifier | EUCT number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-90009530 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-90009530 | Drug | JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 24 months |
| Determine the time to response (TTR) |
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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
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 Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospital | Iowa City | Iowa | 52242 | United States | ||
| University of Kentucky |
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
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Record the number of days from the date of JNJ-90009530 infusion to a CR or PR
| up to 24 months |
| Determine the duration of response (DOR) | Record the number of days from the date of the first CR or PR to relapse or death. | up to 24 months |
| 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). | up to 24 months |
| Lexington |
| Kentucky |
| 40506 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Rutgers University | New Brunswick | New Jersey | 08901 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Monash Medical Centre | Clayton | 3168 | Australia |
| Austin Hospital | Heidelberg | 3084 | Australia |
| Royal Brisbane and Women's Hospital | Herston | 4029 | Australia |
| Westmead Hospital | Westmead | 2145 | Australia |
| Hadassah Medical Center | Jerusalem | 9112001 | Israel |
| Sheba Medical Center | Ramat Gan | 5266202 | Israel |
| University College London Hospitals | London | NW1 2BU | United Kingdom |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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