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Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies

26. juni 2016 oppdatert av: Innovative Cellular Therapeutics Co., Ltd.

A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01)

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Detaljert beskrivelse

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

Studietype

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Shanghai, Kina
        • Rekruttering
        • Innovative Cellular Therapeutics CO., LTD.
        • Ta kontakt med:
          • Lei Xiao, Ph.D
          • Telefonnummer: +86-21-58950719
        • Hovedetterforsker:
          • He Huang, Ph.D

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

Ikke eldre enn 60 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients diagnosed as CD19 positive refractory and relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL),chronic lymphocytic leukemia(CLL),non-Hodgkin's lymphoma(NHL)
  • not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after hematopoietic stem cell transplant(HSCT)
  • At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm(for patients with NHL )
  • Age ≤60 years
  • Eastern Cooperative Oncology Group(ECOG) Performance status 0 to 2, Expected survival > 6 months
  • Left Ventricular Ejection Fraction (LVEF) > 50%
  • no history of other malignancies;
  • no other serious diseases which conflict with the treatment in the present trial
  • All patients should consent to adopt efficient contraception methods during the treatment and after the treatment. The pregnant tests of women who are in child bearing period should be negative before the treatment.
  • patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment

Exclusion Criteria:

  • Diagnosis or classification undefined
  • Those with primary central nervous system lymphoma or testicular leukaemia or lymphoma
  • Patients with a known history or prior diagnosis of epilepsia or other disease affecting the central nervous system, or serious mental diseases;
  • Patients who have secondary leukaemia or lymphoma after chemotherapy or radiotherapy for other malignancies
  • Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy, concurrent use of immunosuppressant medications
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification
  • Pregnant or lactating women(the safety of this therapy on unborn children is not known)
  • With active infection
  • Active hepatitis B, hepatitis C or syphilis infection
  • Patients use of systemic steroids within 2 weeks. Recent or current use of inhaled steroids is not exclusionary
  • Prior treatment with gene therapy product
  • Cluster of differentiation 3(CD3) positive cells<0.9x10^4/ml in peripheral blood (PB)
  • Organ function meeting following criteria: liver and renal function: alanine aminotransferase(ALT)/aspartate aminotransferase(AST) > 3 times the upper limit of normal, or bilirubin>2.0 mg/dl(34.2umol/L), or creatinine >2.5mg/dl(221.0umol/L) ; hematopoietic function:Neutrophil count<1.0x10^9/L,hemoglobin<80g/L,platelet <50x10^9/L(for patients with NHL )
  • Any uncontrolled active medical disorder that would preclude participation as outlined
  • HIV infection
  • The researchers considered unsuitable to participate in this clinical study.
  • Patients with poor compliance

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: single arm
Experimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg.
Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
Andre navn:
  • CD19-directed chimeric antigen receptor modified T cells

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of study related adverse events
Tidsramme: up to 12 months
up to 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Anti-leukemia or lymphoma responses to CD19CART cell infusions
Tidsramme: up to 24 weeks
up to 24 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Yu Hu, Ph.D, Union Hospital,Tong Ji Medical College,Huazhong University of Science and Technology
  • Studieleder: He Huang, Ph.D, The First Affiliated Hospital of the College of Medicine, Zhejiang University

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

1. juni 2015

Primær fullføring (Forventet)

1. januar 2021

Studiet fullført (Forventet)

1. juli 2021

Datoer for studieregistrering

Først innsendt

19. juni 2016

Først innsendt som oppfylte QC-kriteriene

24. juni 2016

Først lagt ut (Anslag)

27. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. juni 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2016

Sist bekreftet

1. juni 2016

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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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