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Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110640
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : November 27, 2019
Sponsor:
Collaborators:
Hrain Biotechnology Co., Ltd.
Second Affiliated Hospital of Nanchang University
Information provided by (Responsible Party):
Kang YU, First Affiliated Hospital of Wenzhou Medical University

Study Description
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Brief Summary:
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Condition or disease Intervention/treatment Phase
B-cell Adult Acute Lymphoblastic Leukemia B-cell Chronic Lymphocytic Leukemia Adult Acute Lymphoblastic Leukemia in Remission Hematopoietic/Lymphoid Cancer Refractory Chronic Lymphocytic Leukemia Biological: anti-CD19 CAR-T Drug: Fludarabine Drug: Cyclophosphamide Phase 1

Detailed Description:

Primary objectives

  1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives
  2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma
Actual Study Start Date : October 1, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: CD9CAR-T transfer
All subjects will receive allogeneic stem cell transplantation after infusion of αCD19-TCRz-CD28 CAR-T
 Biological: anti-CD19 CAR-T
Ex vivo-expanded autologous T cells modified to express CD19 CAR

Drug: Fludarabine
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.

Drug: Cyclophosphamide
Patients were given cyclophosphamide 500mg/m2/day on day -4.


Outcome Measures
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Primary Outcome Measures :
  1. Safety - incidence of adverse events defined as dose-limited toxicity [ Time Frame: 180 days ]
    incidence of adverse events defined as dose-limited toxicity


Secondary Outcome Measures :
  1. Overall complete remission rate [ Time Frame: 1 year ]
    Overall complete remission rate

  2. Duration of remission [ Time Frame: 1 year ]
    Duration of remission


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 5 Years to 70 Years, Male and female;
  • Expected survival > 12 weeks;
  • Performance score 0-2;
  • Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy
  • Creatinine < 2.5 mg/dl;
  • ALT/AST < 3x normal;
  • Bilirubin < 2.0 mg/dl;
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis;
  • Take contraceptive measures before recruit to this trial;
  • Written voluntary informed consent is given.

Exclusion Criteria:

  • Patients with symptoms of central nervous system
  • Accompanied by other malignant tumor
  • Active hepatitis B or C, HIV infection
  • Any other diseases could affect the outcome of this trial
  • Suffering severe cardiovascular or respiratory disease
  • Poorly controlled hypertension
  • A history of mental illness and poorly controlled
  • Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration
  • Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment
  • Reaching a steady dose if receiving anticoagulant therapy before assignment
  • Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Pregnant or lactating women
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110640


Contacts
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Contact: Kang Yu, M.D. 55578037 yukang62@126.com

Locations
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China, Zhejiang
The First Affilicated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Kang Yu, M.D    55578037    yukang62@126.com   
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
Hrain Biotechnology Co., Ltd.
Second Affiliated Hospital of Nanchang University
Investigators
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Principal Investigator: Kang Yu, M.D. First Affiliated Hospital of Wenzhou Medical University
More Information
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Responsible Party: Kang YU, Principal Investigator, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03110640    
Other Study ID Numbers: 20170316
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
 Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists