C-CAR066 i residiverende eller refraktær B-celle non-Hodgkin lymfom (r/r B-NHL)
En fase Ib multisenter, åpen etikett, studie av C-CAR066, en autolog anti-CD20 CAR T-celleterapi hos voksne pasienter med residiverende eller refraktær B-celle 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?
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Camperdown, Australia, 2050
- Royal Prince Alfred Hospital
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Clayton, Australia, 3168
- Monash Medical Centre
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Heidelberg, Australia, 3084
- Austin Hospital
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Herston, Australia, 4029
- Royal Brisbane and Women's Hospital
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Westmead, Australia, 2145
- Westmead Hospital
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Iowa
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Iowa City, Iowa, Forente stater, 52242
- University of Iowa Hospital
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Kentucky
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Lexington, Kentucky, Forente stater, 40506
- University of Kentucky
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic Rochester
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08901
- Rutgers University
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Ohio
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Cleveland Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania
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Texas
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Houston, Texas, Forente stater, 77030
- MD Anderson Cancer Center
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Ramat Gan, Israel, 5266202
- Sheba Medical Center
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London, Storbritannia, NW1 2BU
- University College London Hospitals
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria
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Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
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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
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Tumor must be cluster of differentiation (CD) 20 positive
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Measurable disease as defined by Lugano 2014 classification
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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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: JNJ-90009530
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JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Calculate the Occurence of Adverse Events
Tidsramme: up to 24 months
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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
|
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Determine Recommended Phase 2 dose (RP2D)
Tidsramme: up to 24 months
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Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities |
up to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Determine the Overall Response (OR)
Tidsramme: up to 24 months
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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
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Determine the time to response (TTR)
Tidsramme: up to 24 months
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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
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Determine the duration of response (DOR)
Tidsramme: up to 24 months
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Record the number of days from the date of the first CR or PR to relapse or death. |
up to 24 months
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Measure the amount of JNJ-90009530 in blood over time
Tidsramme: up to 24 months
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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
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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Neoplasmer
- Sykdomsattributter
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom
- Patologiske tilstander, tegn og symptomer
- Hemic og lymfatiske sykdommer
- Tilbakefall
- Lymfom, B-celle
Andre studie-ID-numre
- 90009530LYM1001
- 90009530LYM1001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-506259-97-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
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