Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes
Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma focused on measuring Anti-CD19 CAR Expressing T cells Therapy, CD19 CAR Gene-Transduced Lymphocyte, Adoptive Immunotherapy, Genetically Engineered Lymphocyte Therapy, Retroviral Vector, Burkitt Lymphoma, Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphomatoid Granulomatosis, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Extranodal NK-T-Cell, Lymphoma, Mantle-Cell, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Experimental, Immune System Diseases
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory B-NHL.
- Evaluable region can be identified by CT scan and is positive by FDG-PET.
- 20 ≤ age ≤ 70 years at the time of informed consent.
- ECOG performance status of 0-2.
- Well preserved main organ functions.
- Life expectancy ≥3 months after informed consent.
- Written informed consent.
Exclusion Criteria:
- Other active malignancy.
- CNS infiltration of lymphoma.
- History of allogeneic stem cell transplantation.
- Already participated in a clinical trial in which CD19-CAR-T are administered within 24 weeks.
- Concurrent use of systemic steroids or immunosuppressive agents.
- Concurrent severe heart disease.
- History of severe cerebrovascular disease or sequela including paralysis.
- Known active or severe infection.
- HIV seropositive status.
- HBsAg-positive or both HBcAb and HBV-DNA positive.
- Active hepatitis C.
- Psychiatric disorder or drug addiction that affects the ability of informed consent.
- Pregnant or breastfeeding women, women who may be pregnant and women desiring to become pregnant. Men who desire impregnating a woman are also excluded (excluded: in case when sperm is cryopreserved prior to gene therapy and a child is born by using the sperm).
- Any other patients judged by the investigators to be inappropriate for the subject of this study.
Sites / Locations
- Jichi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Level -1
Dose Level 1
Dose Level 2
Dose Level 3
Cyclophosphamide or Bendamustine as Pre-treatment, and in combination with CD19-CAR-T. In case when sufficient cell number of CD19-CAR-T has been manufactured, the physician judges whether the 2nd infusion of CD19-CAR-T should be performed based on the condition of the subject.
Cyclophosphamide or Bendamustine as Pre-treatment, and in combination with CD19-CAR-T. In case when sufficient cell number of CD19-CAR-T has been manufactured, the physician judges whether the 2nd infusion of CD19-CAR-T should be performed based on the condition of the subject.
Cyclophosphamide or Bendamustine as Pre-treatment, and in combination with CD19-CAR-T. In case when sufficient cell number of CD19-CAR-T has been manufactured, the physician judges whether the 2nd infusion of CD19-CAR-T should be performed based on the condition of the subject.
Cyclophosphamide or Bendamustine as Pre-treatment, and in combination with CD19-CAR-T. In case when sufficient cell number of CD19-CAR-T has been manufactured, the physician judges whether the 2nd infusion of CD19-CAR-T should be performed based on the condition of the subject.