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 antige

Phase 1

Recruiting

• Conditions: Relapsed/Refractory CD19+ B-NH

• Registration Number: JPRN-UMIN000015617
• Lead Sponsor: Jichi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
# Quality test of anti-CD19 CAR expressing T cells (CD19-CAR-T) # Safety: Adverse events, laboratory tests (hematology, serum chemistry, immunological, and infectious disease) # Replication competent retrovirus (RCR) test # Linear amplification mediated-PCR (LAM-PCR)

Secondary Outcome Measures

Name	Time	Method
# Antitumor effect of CD19-CAR-T # Lymphocyte subset analysis of CD19-CAR-T # Immunogenicity of CD19-CAR-T