- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07613788
Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
23. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Weili Zhao
- Telefonnummer: +862164370045 Ext. 610707
- E-post: zwl_trial@163.com
Studer Kontakt Backup
- Navn: Rong Shen
- Telefonnummer: +862164370045 Ext. 610707
- E-post: rongshen510@yeah.net
Studiesteder
-
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China
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Shanghai, China, Kina, 200020
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Ta kontakt med:
- Weili Zhao
- Telefonnummer: 64370045
- E-post: zwl_trial@163.com
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Complete Response Rate at 6 Months
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Objective Response Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. november 2028
Studiet fullført (Antatt)
1. april 2029
Datoer for studieregistrering
Først innsendt
23. mai 2026
Først innsendt som oppfylte QC-kriteriene
23. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Sykdomsattributter
- Patologiske tilstander, tegn og symptomer
- Tilbakefall
- Organiske kjemikalier
- Hydrokarboner
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Hydrokarboner, halogenert
- Fosforamider
- Organofosforforbindelser
- Cyklofosfamid
- fludarabin
- Obinutuzumab
- Glofitamab
- Rimegeepant sulfat
Andre studie-ID-numre
- RIME-CART
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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