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Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.

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ClinicalTrials.gov Identifier: NCT03929107
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Zhejiang Provincial Tongde Hospital
Information provided by (Responsible Party):
Wenbin Qian, First Affiliated Hospital of Zhejiang University

Brief Summary:
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Intervention group
In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated.
Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.




Primary Outcome Measures :
  1. complete remission rate [ Time Frame: at the time point 3 months after CAR-T cell transfusion ]
    complete remission rate after treated by CAR-T therapy

  2. adverse events [ Time Frame: from the date of the start of treatment to 24 months after last patient's enrollment ]
    any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure


Secondary Outcome Measures :
  1. progression free surviva [ Time Frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment ]
    from date of inclusion to date of progression, relapse, or death from any cause

  2. overall survival [ Time Frame: from the day of treatment to the date of first documented progression,up to 24 months after the last patient's enrollment ]
    from the date of inclusion to date of death, irrespective of cause

  3. duration of the CAR-T cells in the patients [ Time Frame: from the date of re-transfusison to 24 months after last patient's enrollment ]
    time from re-transfusion to date when the modified T cells become non-detectable.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Age 18-75 years old, male or female;
  • 2. ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria;
  • 3. Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL;
  • 4. CD19 positive (by immuno-histology or flowcytometry) [for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable];
  • 5. Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease <6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation.

    2) definition of refractory/relapsed disease for CLL and other indolent B cell NHL, should fit one of the following: ① failed or relapsed after 2nd therapy (Rituximab must be included) and being unable to accept ibrutinib treatment due to various reasons; ② non-responsive or intolerable to ibrutinib as 2nd line treatment; 3) refractory or relapsed MCL should fit one of the following: ① complete remission not achieved after 2nd line treatment; ② disease progression during treatment; ③duration of stable disease ≤6 months; ④disease progress or relapse within 12 months of autologous stem cell transplantation.

  • 6. Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines;
  • 7. Patients should have at least one measurable disease focus, with the longitudinal diameter ≥1.5cm, or any extra-nodal focus with the longitudinal diameter ≥1.0cm, with PET/CT positive results;
  • 8. Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul;
  • 9. Cardiac, hepatic and renal function: Creatinin <1.5 times of normal maximum;ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of ULN;cardiac ejection fraction≥ 50%;
  • 10. Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent;
  • 11. Fertile patients should agree to take contraceptive measures during the process of this trial.

Exclusion Criteria:

  • 1. History of other malignant tumor;
  • 2. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
  • 3. Received CAR-T therapy within 3 months prior to enrollment;
  • 4. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection;
  • 5. With active autoimmune disease;
  • 6. With active infection;
  • 7. With HIV infection, or uncontrolled HBV/HCV/syphilis infection;
  • 8. With known central nervous system lymphoma.

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): NCT03929107


Contacts
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Contact: Juying Wei, MD (+86)13867476302 weijuy@hotmail.com
Contact: Hui Liu, MD,PhD (+86)13819198629

Locations
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China, Zhejiang
The first affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Wenbin Qian, MD,PhD    (+86)13605801032    qianwenb@aliyun.com   
Sponsors and Collaborators
Wenbin Qian
Zhejiang Provincial Tongde Hospital
Investigators
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Principal Investigator: Wenbin Qian, MD,PhD Zhejiang University

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Responsible Party: Wenbin Qian, Doctor, Professor, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT03929107     History of Changes
Other Study ID Numbers: lymphoma center Q003
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 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 Wenbin Qian, First Affiliated Hospital of Zhejiang University:
interleukin 7, Chemokine (C-C Motif) Ligand 19, CAR-T

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin