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CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984968
Recruitment Status : Enrolling by invitation
First Posted : June 13, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University

Brief Summary:
CD19 CAR-T therapy is an effective treatment choice for refractory/relapsed acute B-lymphoblastic leukemia, but relapse after CAR-T treatment still occurs and is the main reason for CAR-T treatment failure. The exhaustion of CAR-T cells and the subsequent inability to maintain CAR-T cell killing effect were major underlying factors for relapse and there was no solution so far. In this study, T cells expressing CD19 antigen (feeding T cell) were constructed and expanded in vitro. Feeding T cells and CD19 CAR-T cells were infused back into the patients sequentially to continuously stimulate CD19 CAR-T cells so as to enhance the therapeutic effect and reduce the relapse rate.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia, Adult B-Cell Biological: CAR-T infusion Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Safety and Efficacy of CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia Concomitant With Infusion of CD19+T Cells as Feeding Cells
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: CAR-T infusion
CAR-T cells and feeding T cells were infused into remission patients sequentially,with 5*10e6/kg and 1*10e7/kg respectively for each cycle. Each patient underwent 3 cyles of CAR-T consolidation therapies and was followed up for 2 years.
Biological: CAR-T infusion
Patients enrolled in this arm will receive CAR-T infusion




Primary Outcome Measures :
  1. Overall survial [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  2. Event free survival [ Time Frame: 2 year ]
    It is measured from the date of entry into this trial to the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.


Secondary Outcome Measures :
  1. Hypocytosis [ Time Frame: 6 months ]
    Events of Hypocytosis after CAR-T infusion



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ph+ acute B-lymphoblastic leukemia patients having received once CD19 CAR-T therapy
  • continuously taking TKI medications
  • no chance to receive allogeneic hematopoietic stem cell transplantation
  • no severe complications
  • ECOG score less than 3

Exclusion Criteria:

  • Detection of mutations on abl gene
  • resistance to TKI medications

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): NCT03984968


Locations
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China, Jiangsu
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University

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Responsible Party: Sheng-Li Xue, MD, Associate Professor, The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03984968     History of Changes
Other Study ID Numbers: SZCART01
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University:
feeding T cell
CD19 CAR-T therapy

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases