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CAR-T Cell Therapy Targeting to CD19 for R/R ALL

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ClinicalTrials.gov Identifier: NCT03919240
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Information provided by (Responsible Party):
The First Affiliated Hospital of Soochow University

Brief Summary:
Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct a trial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia With Failed Remission Biological: CAR T-cell therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: CAR T-cell therapy
Patients enrolled will receive infusion of CD19-targeting CAR T-cells
Biological: CAR T-cell therapy
Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).




Primary Outcome Measures :
  1. Complete remission [ Time Frame: 1 month post infusion ]
    defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery

  2. Minimal residual disease response [ Time Frame: 1 month post infusion ]
    defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection

  3. Cytokine release syndrome [ Time Frame: 1 month post infusion ]
    grading according to the criteria proposed by Lee, et al (Blood, 2014, 124: 188-195). This grading system ranges from grade 1 (best) to grade 5 (worst), by measuring related symptoms (such as fever, nausea, fatigue, headache, etc.), oxygen requirement, blood pressure and organ toxicity (referred to CTCAE v4.0 grading)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year post infusion ]
    calculating from the day of CAR T-cell infusion to death or the end of follow-up

  2. Leukemia-free survival [ Time Frame: 1 year post infusion ]
    calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up

  3. Cumulative incidence of relapse [ Time Frame: 1 year post infusion ]
    calculating from the day of CAR T-cell infusion to disease progression or the end of follow-up



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
  • Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
  • With an estimated survival of higher than 3 months (according to investigator's judgement);
  • Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine < 1.6 mg/dL, aspartate aminotransferase/aspartate aminotransferase < 3 x upper limit of normal, bilirubin <2.0 mg/dL;
  • Karnofsky performance status ≥ 60 or ECOG ≤ 2.

Exclusion Criteria:

  • Intolerant to immunosuppressive chemotherapies;
  • With active infection or other uncontrolled complications;
  • With history of seizure;
  • Active hepatitis B or hepatitis C infection and HIV infection;
  • Pregnant or lactating women, or patients refusing to take effective contraception measures;
  • Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).

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): NCT03919240


Contacts
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Contact: Jia Chen, M.D., Ph.D. +86 512 67781856 drchenjia@163.com
Contact: Xiang Zhang, M.D. +86 512 67781856 lcsy2013@sina.com

Locations
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China, Jiangsu
The Fisrt Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Depei Wu, M.D., Ph.D.    +86 512 6778 1856    wudepei@medmail.com.cn   
Contact: Jia Chen, M.D.    +86 512 6778 1856    chenjia@suda.edu.cn   
Principal Investigator: Depei Wu, M.D., Ph.D.         
Sub-Investigator: Jia Chen, M.D.         
Sub-Investigator: Aining Sun, M.D., Ph.D.         
Sub-Investigator: Huiying Qiu, M.D., Ph.D.         
Sub-Investigator: Xiaowen Tang, M.D., Ph.D.         
Sub-Investigator: Yue Han, M.D., Ph.D.         
Sub-Investigator: Zhengming Jin, M.D.         
Sub-Investigator: Chengcheng Fu, M.D., Ph.D.         
Sub-Investigator: Feng Chen, M.D., Ph.D.         
Sub-Investigator: Xiao Ma, M.D., Ph.D.         
Sub-Investigator: Suning Chen, M.D., Ph.D.         
Sub-Investigator: Xiang Zhang, M.D.         
Sponsors and Collaborators
The First Affiliated Hospital of Soochow University
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Publications:
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Responsible Party: The First Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT03919240     History of Changes
Other Study ID Numbers: SZ4601
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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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 The First Affiliated Hospital of Soochow University:
Acute Lymphoblastic Leukemia
Refractory and relapsed
Chimeric antigen receptor T-cell 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