- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05149391
A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma
24. november 2021 oppdatert av: Jun Zhu, Peking University
A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma
This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.
Studietype
Intervensjonell
Registrering (Forventet)
18
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yuqin Song, PhD&MD
- Telefonnummer: 010- 88196118
- E-post: SongYQ_VIP@163.com
Studiesteder
-
-
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Beijing, Kina
- Rekruttering
- Peking university cancer hospital
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Ta kontakt med:
- Yuqin Song, PhD&MD
- Telefonnummer: 010- 88196118
- E-post: SongYQ_VIP@163.com
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Hovedetterforsker:
- Yuqin Song, PhD&MD
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Underetterforsker:
- Zhitao Ying
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Underetterforsker:
- Yongjing Tang
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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
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- The patient volunteered to participate in the study and signed the Informed Consent;
- Age, 18-70 years (include 18 and 70), male or female;
- Expected survival ≥ 12 weeks
- Eastern Cooperative Oncology Group score 0-2
- CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
- Diffuse Large B Cell Lymphoma, Non Specifically
- Primary Mediastinal B-cell Lymphoma
- Transformed Follicular Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
- High Grade B-Cell Lymphoma, Non Specifically
- For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
- No contraindications of apheresis.
- At least one measurable lesion according to Lugano 2014 criteria;
Adequate organ function and adequate bone marrow reserve
- Hemoglobin≥80 g/L
- Absolute neutrophil count≥1.0×109/L
- Platelet≥50×109/L,
- Creatinine≤1.5×upper limit of the normal range (ULN)
- Cardiac ejection fraction≥50%
- Saturation of Pulse Oxygen>92%
- Total bilirubin≤1.5×ULN
- Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN
Exclusion Criteria:
- Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
- Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponema pallidum infection ;
- Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need treatment;
- Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion;
- Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
- Patients who have been previously infected with tuberculosis;
- Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
- Patients with central nervous system involvement;
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: C-CAR039
Autolog C-CAR039 administrert ved intravenøs (IV) infusjon
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Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Safety Observation
Tidsramme: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
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Incidence of adverse events after C-CAR039 infusion.
Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity
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up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maximum concentration (Cmax) of C-CAR039 in the peripheral blood.
Tidsramme: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Detect Chimeric Antigen Receptor-T copies number by quantitative polymerase chain reaction(qPCR).
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Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.
Tidsramme: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Detect Chimeric Antigen Receptor-T copies number by qPCR.
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Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.
Tidsramme: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Detect Chimeric Antigen Receptor-T copies number by qPCR.
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Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
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Area under the curve 0h-28d of C-CAR039 in the peripheral blood.
Tidsramme: Baseline, Days 4, 7, 10 and weeks 2, 3, 4
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Detect Chimeric Antigen Receptor-T copies number by qPCR.
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Baseline, Days 4, 7, 10 and weeks 2, 3, 4
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Overall response rate (ORR)
Tidsramme: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria.
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4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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Duration of response (DOR)
Tidsramme: up to 24 months
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The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion.
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up to 24 months
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Progression-free survival (PFS)
Tidsramme: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death.
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4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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Overall survival (OS)
Tidsramme: up to 24 months
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The time from C-CAR039 infusion to the date of death.
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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
Samarbeidspartnere
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 (Faktiske)
20. juli 2021
Primær fullføring (Forventet)
1. juli 2024
Studiet fullført (Forventet)
1. oktober 2024
Datoer for studieregistrering
Først innsendt
9. november 2021
Først innsendt som oppfylte QC-kriteriene
24. november 2021
Først lagt ut (Faktiske)
8. desember 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. desember 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. november 2021
Sist bekreftet
1. november 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 0702-022
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
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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