JPRN-UMIN000015617RecruitingPhase 1
Clinical Research of gene therapy for relapsed or refractory B-cell Non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen - Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Jichi Medical University
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 70years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1. Other active malignancy. 2. CNS infiltration of lymphoma. 3. History of allogeneic stem cell transplantation. 4. Already participated in a clinical trial in which CD19-CAR-T are administered within 24 weeks. 5. Concurrent use of systemic steroids or immunosuppressive agents. 6. Concurrent severe heart disease 7. History of severe cerebrovascular disease or sequela including paralysis 8. Known active or severe infection. 9. HIV seropositive status 10. HBsAg-positive or both HBcAb and HBV-DNA positive. 11. Active hepatitis C. 12. Psychiatric disorder or drug addiction that affects the ability of informed consent. 13. 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). 14. Any other patients judged by the investigators to be inappropriate for the subject of this study.
Investigators
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