Trial Radar IA
Lo studio clinico NCT07225439 per Linfoma Non Hodgkin, Linfoma non Hodgkin a cellule B, Linfoma a Grandi Cellule B Diffuso, Linfoma a Cellule B di Alto Grado, Linfoma a Grandi Cellule B del Mediastino Primario, Linfoma Follicolare, Leucemia linfatica cronica, Linfoma Linfocitico Cronico, Linfoma della Zona Marginale, Linfoma a Cellule del Mantello è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) Fase I 15

Non ancora in arruolamento
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La sperimentazione clinica NCT07225439 è uno studio interventistico di Fase I volto a esaminare il trattamento per Linfoma Non Hodgkin, Linfoma non Hodgkin a cellule B, Linfoma a Grandi Cellule B Diffuso, Linfoma a Cellule B di Alto Grado, Linfoma a Grandi Cellule B del Mediastino Primario, Linfoma Follicolare, Leucemia linfatica cronica, Linfoma Linfocitico Cronico, Linfoma della Zona Marginale, Linfoma a Cellule del Mantello, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 dicembre 2025, con l'obiettivo di raggiungere 15 partecipanti. Sotto la guida di Paolo Caimi, MD, dovrebbe concludersi entro il 1 dicembre 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 6 novembre ...

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Sommario breve
This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.

NK cells are an investigational (experimental) tr...

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Descrizione dettagliata
More than 80,000 cases of non-Hodgkin lymphoma (NHL) are diagnosed each year in the United States (US), with nearly 20,000 people dying from this group of diseases annually. There are several subgroups of NHL, with the B cell lymphomas being much more common than T-cell lymphomas. B cell lymphomas include multiple different diseases, including some that are more aggressive (like diffuse large B cell lymphoma (DLBCL) ...Mostra di più
Titolo ufficiale

Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma

Patologie
Linfoma Non HodgkinLinfoma non Hodgkin a cellule BLinfoma a Grandi Cellule B DiffusoLinfoma a Cellule B di Alto GradoLinfoma a Grandi Cellule B del Mediastino PrimarioLinfoma FollicolareLeucemia linfatica cronicaLinfoma Linfocitico CronicoLinfoma della Zona MarginaleLinfoma a Cellule del Mantello
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
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Altri ID dello studio
  • CASE1425
Numero NCT
NCT07225439
Data di inizio (effettiva)
2025-12
Ultimo aggiornamento pubblicato
2025-11-06
Data di completamento (stimata)
2027-12
Arruolamento (previsto)
15
Tipo di studio
Interventistico
FASE
Fase I
Stato
Non ancora in arruolamento
Parole chiave
NK cells
Natural Killer cells
Scopo principale
Trattamento
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleRtx + Tafasitamab in combination with allogeneic NK Cells
This arm includes dose escalation for allogeneic NK cells. All other therapies are given according to standard of care. The length of the treatment period is 28 days per cycle. Participants will be expected to complete one cycle and may have the option to complete a second cycle unless there is evidence of disease progression at the end of the first cycle.
Allogeneic NK cells
Allogeneic NK cells are given intravenously (IV) weekly for 3 weeks on Days 0, 7, 14. Dose escalation will be conducted using a Bayesian optimal interval (BOIN) design starting at dose level 1 (500 x 106 cells) and proceeding to dose level 2 (1,000 x 106 cells) if criteria are met.
Rituximab
Rtx is dosed at 375mg/m2 and give once (on Day -5 for Cycle 1 and Day 0 for Cycle 2, if applicable).
Tafasitamab
Tafasitamab is dosed at 12 mg/kg and given intravenously (IV) weekly for 3 weeks on Days 0,7,14).
Interleukin-2
Interleukin-2 is dosed at 5 million IU and given weekly for 3 weeks on Days 0,7,14.
Fludarabine/cyclophosphamide
Fludarabine is dosed at 30 mg/m2/d with dose adjustment for renal function, and cyclophosphamide is dosed at 500 mg/m2/d. These are given on 3 days (Days -5 to -3).
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Dose limiting toxicity (DLT)
Non hematologic AEs will be measured during cycle 1 (first 28 days) and hematologic AEs will be measured during the first 42 days for all dose levels. DLTs are graded for severity by the Common Terminology Criteria for Adverse Events v5.0 (CTCAEv5.0) criteria.
Up to 42 days
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Incidence of adverse events (AEs)
Up to 12 months
Timing of adverse events (AEs)
Up to 12 months
Severity of adverse events (AEs)
AE severity will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Up to 12 months
Complete response (CR) rate
CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria.
Day 28
Complete response (CR) rate
CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria.
Day 100
Overall response rate (ORR)
ORR is defined as the rate of participants who had CR and partial response (PR). CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. PR is defined as not meeting criteria for CR but having an improvement in symptom criteria specified by the 2014 Lugano Response for Malignant Lymphoma criteria.
Day 28
Overall response rate (ORR)
ORR is defined as the rate of participants who had CR and partial response (PR). CR is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy and measured according to the 2014 Lugano Response for Malignant Lymphoma criteria. PR is defined as not meeting criteria for CR but having an improvement in symptom criteria specified by the 2014 Lugano Response for Malignant Lymphoma criteria.
Day 100
Overall survival (OS)
OS is defined as the time from infusion until death from any cause, or until last contact if alive
Up to 12 months
Event-free survival (EFS)
EFS is defined as the time from infusion until the first occurrence of an event (relapse, progression, or death from any cause), or until last contact if no event occurs.
Up to 12 months
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • Age 18 years or older
  • Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)
  • Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET/CT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹/L), lymphadenopathy ≥1.5 cm, and/or disease-related cytopenias (anemia, thrombocytopenia).
  • Relapsed and/or refractory after two or more lines of systemic therapy, including prior CD19 and/or CD20 directed therapies
  • For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and/or CD20 expression (by flow cytometry and/or immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy
  • ECOG Performance Status </= 2
  • Preserved organ function as defined by: Total bilirubin </= 1.5X upper limit of normal; AST/ALT </= 2.5 X upper limit of normal; Calculated creatinine clearance >/= 30mL/min estimated by Cockcroft Gualt formula; cardiac ejection fraction >/= 45% and no more than mild/trace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation >/= 92% on room air.
  • Participants must have the ability to understand and the willingness to sign a written informed consent document

  • Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator
  • Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment
  • New York Heart Association class III-IV congestive heart failure
  • Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration
  • Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load <200 copies/mL on antiretroviral therapy
  • Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study
  • Morphologic and/or cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy
  • Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)
  • Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease
  • Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration
  • History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \[i.e. maximum of 15mg prednisone equivalent\] within the last 6 months
Paolo Caimi, MD logoPaolo Caimi, MD
Incyte Corporation logoIncyte
Parte responsabile dello studio
Paolo Caimi, MD, Promotore-investigatore, Principal Investigator, Case Comprehensive Cancer Center
Contatti principali dello studio
Contatto: Paolo Caimi, MD, (216) 445-4635, [email protected]
2 Centri dello studio in 1 paesi

Ohio

Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center, Cleveland, Ohio, 44106, United States
Changchun (George) Deng, Contatto, [email protected]
Changchun (George) Deng, MD, Investigatore principale
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute, Cleveland, Ohio, 44195, United States
Paolo Caimi, MD, Contatto, [email protected]
Paolo Caimi, MD, Investigatore principale