Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes

• Status: Unknown status
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jichi Medical University
• Collaborator: Takara Bio Inc.
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide

Criteria

Inclusion Criteria:

1. Relapsed or refractory B-NHL.

2. Evaluable region can be identified by CT scan and is positive by FDG-PET.

3. 20 ≤ age ≤ 70 years at the time of informed consent.

4. ECOG performance status of 0-2.

5. Well preserved main organ functions.

6. Life expectancy ≥3 months after informed consent.

7. Written informed consent.

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.