search
Back to results

Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

Primary Purpose

Leukemia, B-Cell

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CD19-targeted CART cells
Sponsored by
jiuwei cui
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, B-Cell focused on measuring Chimeric Antigen Receptor-Modified T Cells, CART, Recurrent B Cell Acute Lymphoblastic Leukemia, refractory B Cell Acute Lymphoblastic Leukemia, ALL

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL)
  • Patients who have failed at least one line of a standard treatment without effective treatment measures at present
  • CD19 expression on the surface of B-ALL cells must be detected
  • KPS>80
  • Life expectancy >3 months
  • Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of > 90%, and adequate renal function (Cr≤2.5 times of the normal range)
  • The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L)
  • Hemoglobin(Hgb)≥80g/L
  • Without contraindication of apheresis and cell isolation
  • Patients and their families volunteer to participate in the research with signed written informed consent

Exclusion Criteria:

.Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease.

  • Evidence of uncontrolled current serious active infection
  • HIV/HBV/HCV infection
  • Pregnancy and nursing females
  • Systemic glucocorticoid therapy within one week

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    B-ALL treated with CD19 CART cell

    Arm Description

    The qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.

    Outcomes

    Primary Outcome Measures

    overall response rate(ORR)
    ORR is defined as the proportion of partial responses plus complete responses.

    Secondary Outcome Measures

    Progression free survival(PFS)
    Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause).
    Overall survival(OS)
    Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact.

    Full Information

    First Posted
    July 15, 2018
    Last Updated
    February 24, 2019
    Sponsor
    jiuwei cui
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03599375
    Brief Title
    Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia
    Official Title
    Safety and Clinical Activity of CD19 Chimeric Antigen Receptor T Cells in Treating Patients With Recurrent or Refractory CD19 Positive B Cell Acute Lymphoblastic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2020 (Anticipated)
    Study Completion Date
    December 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    jiuwei cui

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.
    Detailed Description
    In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia, B-Cell
    Keywords
    Chimeric Antigen Receptor-Modified T Cells, CART, Recurrent B Cell Acute Lymphoblastic Leukemia, refractory B Cell Acute Lymphoblastic Leukemia, ALL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Model Description
    Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    B-ALL treated with CD19 CART cell
    Arm Type
    Experimental
    Arm Description
    The qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.
    Intervention Type
    Biological
    Intervention Name(s)
    CD19-targeted CART cells
    Intervention Description
    CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.
    Primary Outcome Measure Information:
    Title
    overall response rate(ORR)
    Description
    ORR is defined as the proportion of partial responses plus complete responses.
    Time Frame
    Participants will be followed for the duration of the treatment, with an expected average of 3 months.
    Secondary Outcome Measure Information:
    Title
    Progression free survival(PFS)
    Description
    Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause).
    Time Frame
    15 years
    Title
    Overall survival(OS)
    Description
    Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact.
    Time Frame
    15 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL) Patients who have failed at least one line of a standard treatment without effective treatment measures at present CD19 expression on the surface of B-ALL cells must be detected KPS>80 Life expectancy >3 months Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of > 90%, and adequate renal function (Cr≤2.5 times of the normal range) The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L) Hemoglobin(Hgb)≥80g/L Without contraindication of apheresis and cell isolation Patients and their families volunteer to participate in the research with signed written informed consent Exclusion Criteria: .Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease. Evidence of uncontrolled current serious active infection HIV/HBV/HCV infection Pregnancy and nursing females Systemic glucocorticoid therapy within one week

    12. IPD Sharing Statement

    Learn more about this trial

    Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

    We'll reach out to this number within 24 hrs