C-CAR066 i återfallande eller refraktärt B-cells non-Hodgkin-lymfom (r/r B-NHL)
En fas Ib multicenter, öppen studie av C-CAR066, en autolog anti-CD20 CAR T-cellsterapi hos vuxna patienter med återfall eller refraktärt B-cells non-Hodgkin lymfom
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?
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
-
Camperdown, Australien, 2050
- Royal Prince Alfred Hospital
-
Clayton, Australien, 3168
- Monash Medical Centre
-
Heidelberg, Australien, 3084
- Austin Hospital
-
Herston, Australien, 4029
- Royal Brisbane and Women's Hospital
-
Westmead, Australien, 2145
- Westmead Hospital
-
-
-
-
Iowa
-
Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa Hospital
-
-
Kentucky
-
Lexington, Kentucky, Förenta staterna, 40506
- University of Kentucky
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Rochester
-
-
New Jersey
-
New Brunswick, New Jersey, Förenta staterna, 08901
- Rutgers University
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44106
- University Hospitals Cleveland Medical Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- MD Anderson Cancer Center
-
-
-
-
-
Jerusalem, Israel, 9112001
- Hadassah Medical Center
-
Ramat Gan, Israel, 5266202
- Sheba Medical Center
-
-
-
-
-
London, Storbritannien, NW1 2BU
- University College London Hospitals
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 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, 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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: JNJ-90009530
|
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Calculate the Occurence of Adverse Events
Tidsram: up to 24 months
|
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)
Tidsram: up to 24 months
|
Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities |
up to 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Determine the Overall Response (OR)
Tidsram: up to 24 months
|
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)
Tidsram: up to 24 months
|
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)
Tidsram: up to 24 months
|
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
Tidsram: up to 24 months
|
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
|
Samarbetspartners och utredare
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer
- Sjukdomsegenskaper
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom
- Patologiska tillstånd, tecken och symtom
- Hemiska och lymfsjukdomar
- Upprepning
- Lymfom, B-cell
Andra studie-ID-nummer
- 90009530LYM1001
- 90009530LYM1001 (Annan identifierare: Janssen Research & Development, LLC)
- 2023-506259-97-00 (Registeridentifierare: EUCT number)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .