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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Weili Zhao
- Numero di telefono: +862164370045 Ext. 610707
- Email: zwl_trial@163.com
Backup dei contatti dello studio
- Nome: Rong Shen
- Numero di telefono: +862164370045 Ext. 610707
- Email: rongshen510@yeah.net
Luoghi di studio
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China
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Shanghai, China, Cina, 200020
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Contatto:
- Weili Zhao
- Numero di telefono: 64370045
- Email: zwl_trial@163.com
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Complete Response Rate at 6 Months
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Objective Response Rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Attributi della malattia
- Condizioni patologiche, segni e sintomi
- Ricorrenza
- Prodotti chimici organici
- Idrocarburi
- Senape di fosforamide
- Composti di senape di azoto
- Composti di senape
- Idrocarburi, alogenati
- Fosforamidi
- Composti organofosfori
- Ciclofosfamide
- fludarabina
- obinutuzumab
- Glofitamab
- Rimegepant Solfato
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- RIME-CART
Piano per i dati dei singoli partecipanti (IPD)
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