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

26. juni 2016 opdateret af: 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.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Shanghai, Kina
        • Rekruttering
        • Innovative Cellular Therapeutics CO., LTD.
        • Kontakt:
          • Lei Xiao, Ph.D
          • Telefonnummer: +86-21-58950719
        • Ledende efterforsker:
          • He Huang, Ph.D

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 60 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 navne:
  • CD19-directed chimeric antigen receptor modified T cells

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • 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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2015

Primær færdiggørelse (Forventet)

1. januar 2021

Studieafslutning (Forventet)

1. juli 2021

Datoer for studieregistrering

Først indsendt

19. juni 2016

Først indsendt, der opfyldte QC-kriterier

24. juni 2016

Først opslået (Skøn)

27. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Lymfom, B-celle

Abonner