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

Overview

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.

Full Title of Study: “Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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
  • 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
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wenbin Qian
  • Collaborator
    • Zhejiang Provincial Tongde Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Wenbin Qian, Doctor, Professor – First Affiliated Hospital of Zhejiang University
  • Overall Official(s)
    • Wenbin Qian, MD,PhD, Principal Investigator, Zhejiang University
  • Overall Contact(s)
    • Juying Wei, MD, (+86)13867476302, weijuy@hotmail.com

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