CD19-redirected Autologous Cells (CAR-CD19 T Cells)

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed for determining the safety and relative engraftment levels of the redirected autologous T cells transduced with the anti-CD19 lentiviral vector in patients with CD19-positive B cell leukemia and malignant lymphoma.

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

Details

• Lead Sponsor: RenJi Hospital
• Collaborators: CARsgen Therapeutics Co., Ltd.; Carsgen Therapeutics, Ltd.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Subjects with documented CD19-positive malignant B cell leukemia and lymphoma.

1. Patients aged between 18 ~ 65 with malignant B cell leukemia and lymphoma.

2. CD19-positive B cell leukemia or lymphoma.

3. Expected survival > 12 weeks.

4. ECOG scores 0-1, or KPS scores > 80.

5. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.

6. WBC ≥ 2.5×109/L; LY ≥ 0.7×109/L; LY% ≥ 15%.

7. Creatinine ≤ 2.0 mg/dL (176.8 μmol/L).

8. ALT/AST ≤ 2.5 ULN.

9. Bilirubin ≤ 2.0 mg/dL (34.2 μmol/L).

10. Prothrombin Time (PT) : International Normalized Ratio (INR) < 1.7, or PT is at most 4 s longer than normal value.

All tests results should comply with the above criteria. No continuing supportive care is received.

Exclusion Criteria:

• 1. CD19-negative B cell leukemia or lymphoma. 2. Feasibility assessment during screening demonstrates < 5% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to αCD3/CD28 costimulation.

3. Pregnant or lactating women. (The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.) 4. Active hepatitis B or hepatitis C infection. 5. HIV/AIDS infection. 6. Uncontrolled active infection. 7. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

8. Previously treatment with any gene therapy products. 9. Allergy to immunotherapy and associated drugs. 10. Patients with heart disease that is in need of treatment or with poorly controlled hypertension determined by investigators.

11. Patients with unstable or active ulceration or with gastrointestinal bleeding.

12. Patients with previous or planed organ transplantation. 13. Hyponatremia with concentration of sodium in the blood < 125 mmol/L. 14. Serum potassium (baseline) < 3.5 mmol/L (Patients can take potassium supplements to recover serum potassium level prior to participating the study).

15. Patients need anticoagulant (e.g. Warfarin or heparin). 16. Patients need long-term antiplatelet agent (Aspirin, dose > 300 mg/d; Clopidogrel, dose > 75 mg/d).

17. Any radiotherapy conducted within 4 weeks prior to blood sampling.