- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07613788
Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
23. Mai 2026 aktualisiert von: Zhao Weili, Ruijin Hospital
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
This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.
Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant.
The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Interventionell
Einschreibung (Geschätzt)
100
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
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
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
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
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / 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.
|
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
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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
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
|
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
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Mai 2026
Primärer Abschluss (Geschätzt)
1. November 2028
Studienabschluss (Geschätzt)
1. April 2029
Studienanmeldedaten
Zuerst eingereicht
23. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
23. Mai 2026
Zuerst gepostet (Tatsächlich)
29. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
29. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
23. Mai 2026
Zuletzt verifiziert
1. Mai 2026
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
- RIME-CART
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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