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Treatment of Relapsed and/or Chemotherapy Refractory CD33 Positive Acute Myeloid Leukemia by CART-33 (CART33)

26. januar 2016 opdateret af: Han weidong, Chinese PLA General Hospital

Clinical Study of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Acute Myeloid Leukemias

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD33 vector (referred to as CART-33 cells).

II. Determine duration of in vivo survival of CART-33 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-33 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-leukemia response due to CART-33 cell infusions.

II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-33 TCR zeta:CD137 and TCR zeta cells over time.

III. Estimate relative trafficking of CART-33 cells in bone marrow.

IV. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by CART-33 cells in vitro.

V. Determine if cellular or humoral host immunity develops against the murine anti-CD33, and assess correlation with loss of detectable CART-33 (loss of engraftment).

VI. Determine the relative subsets of CART-33 T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-CD33-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Rekruttering
        • Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital, Hematological Department, Affiliated Hospital of Changzhi Medical College
        • Kontakt:
        • Underforsker:
          • Ying Liu, Dr.

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

5 år til 90 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled

    • CD33+ acute myeloid leukemia CR can not be achieved after at least 2 prior combination chemotherapy regimens.

AML in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.

Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).

Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.

Residual disease after primary therapy and not eligible for autologous SCT

  • Expected survival > 12 weeks
  • Creatinine < 2.5 mg/dl
  • ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal
  • Bilirubin < 2.0 mg/dl
  • Any relapse after prior SCT will make patient eligible regardless of other prior therapy
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Voluntary informed consent is given

Exclusion Criteria:

  • Pregnant or lactating women

    • The safety of this therapy on unborn children is not known
    • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
    • Uncontrolled active infection
    • Active hepatitis B or hepatitis C infection
    • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
    • Previously treatment with any gene therapy products
    • Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137 costimulation
    • Any uncontrolled active medical disorder that would preclude participation as outlined
    • HIV infection

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: anti-CD33 CAR T cells
Patients receive anti-CD33-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.
Biologisk: CART33 cells
genetically modified lymphocyte therapy
Andre navne:
  • chimeric antigen receptor T cells with specificity for CD33
Biologisk: anti-CD33 CART
Andre navne:
  • CART33
Biologisk: anti-CD33 CAR T cells

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst af undersøgelsesrelaterede bivirkninger
Tidsramme: Indtil uge 24
defineret som >= Grad 3 tegn/symptomer, laboratorietoksiciteter og kliniske hændelser), der er muligvis, sandsynlige eller definitivt relateret til undersøgelsesbehandling
Indtil uge 24

Sekundære resultatmål

Resultatmål
Tidsramme
Anti-leukemia responses to CART-33 cell infusions
Tidsramme: up to 24 weeks
up to 24 weeks

Andre resultatmål

Resultatmål
Tidsramme
in vivo existence of CART33
Tidsramme: 1 year
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Chinese PLA General Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. april 2013

Primær færdiggørelse (Forventet)

1. april 2016

Studieafslutning (Forventet)

1. april 2017

Datoer for studieregistrering

Først indsendt

20. maj 2013

Først indsendt, der opfyldte QC-kriterier

26. maj 2013

Først opslået (Skøn)

30. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CHN-PLAGH-BT-006

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 Relapsed Adult Myeloid Leukemia

Kliniske forsøg med CART33 cells

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Betingelser

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Sponsor / samarbejdspartnere

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