Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Weili Zhao
- Telefonnummer: +862164370045 Ext. 610707
- E-Mail: zwl_trial@163.com
Studieren Sie die Kontaktsicherung
- Name: Rong Shen
- Telefonnummer: +862164370045 Ext. 610707
- E-Mail: rongshen510@yeah.net
Studienorte
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China
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Shanghai, China, China, 200020
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Kontakt:
- Weili Zhao
- Telefonnummer: 64370045
- E-Mail: zwl_trial@163.com
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Able to understand and voluntarily sign the written informed consent form.
- Age 18 years or older.
- Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression.
- Relapsed or refractory disease after at least one prior line of systemic therapy.
- Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody.
- Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy.
- Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality.
- ECOG performance status of 0 to 2.
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator.
- Participants of reproductive potential must agree to use effective contraception during the study period.
- Able and willing to comply with the study protocol, in the investigator's judgment.
Exclusion Criteria:
- History of hypersensitivity to any study treatment or related compounds.
- Active or uncontrolled infection requiring systemic treatment.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- Uncontrolled or clinically significant viral infection as defined by the protocol.
- Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment.
- Severe or uncontrolled cardiovascular disease.
- Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment.
- Known or suspected history of hemophagocytic lymphohistiocytosis.
- Recent thromboembolic event before screening.
- History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer.
- Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment.
- Pregnant or breastfeeding women, or participants planning pregnancy during the study period.
- Concurrent participation in another interventional clinical trial.
- Need for prohibited concomitant medications that cannot be discontinued or substituted.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study participation.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Experimental: Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy
Participants will receive rimegepant in combination with glofitamab and CD19 CAR-T cell therapy.
Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.
Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy.
Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
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Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.
Glofitamab will be administered intravenously with step-up dosing.
Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy.
The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
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Aktiver Komparator: Glofitamab Plus CD19 CAR-T Cell Therapy
Participants will receive glofitamab in combination with CD19 CAR-T cell therapy.
Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy.
Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol.
|
Glofitamab will be administered intravenously with step-up dosing.
Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy.
The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Complete Response Rate at 6 Months
Zeitfenster: 6 months after CAR-T cell infusion
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Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion.
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6 months after CAR-T cell infusion
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Objective Response Rate
Zeitfenster: Up to 24 months
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Objective response rate is defined as the proportion of participants who achieve complete response or partial response.
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Up to 24 months
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Complete Response Rate at Day 28
Zeitfenster: Day 28 after CAR-T cell infusion
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Complete response rate at Day 28 is defined as the proportion of participants who achieve complete response at Day 28 after CAR-T cell infusion.
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Day 28 after CAR-T cell infusion
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Complete Response Rate at 3 Months
Zeitfenster: 3 months after CAR-T cell infusion
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Complete response rate at 3 months is defined as the proportion of participants who achieve complete response at 3 months after CAR-T cell infusion.
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3 months after CAR-T cell infusion
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Progression-Free Survival
Zeitfenster: Up to 24 months
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Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
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Duration of Response
Zeitfenster: Up to 24 months
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Duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
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Up to 24 months
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Overall Survival
Zeitfenster: Up to 24 months
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Overall survival is defined as the time from randomization to death from any cause.
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Up to 24 months
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Adverse Events
Zeitfenster: Up to 24 months
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Incidence and severity of adverse events will be assessed throughout the study.
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Up to 24 months
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Krankheitsattribute
- Pathologische Zustände, Anzeichen und Symptome
- Wiederauftreten
- Organische Chemikalien
- Kohlenwasserstoffe
- Phosphoramid -Senf
- Stickstoffsenfverbindungen
- Senfverbindungen
- Kohlenwasserstoffe, halogeniert
- Phosphoramide
- Organophosphorverbindungen
- Cyclophosphamid
- Fludarabine
- Obinutuzumab
- Glofitamab
- Rimegepant -Sulfat
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- RIME-CART
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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