CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

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

Details

• Lead Sponsor: Shenzhen Second People's Hospital
• Collaborator: The Beijing Pregene Science and Technology Company, Ltd.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• 1. 18 years to 70 years, expected survival > 3 months;

• 2. CD19 positive B-cell lymphoma;

• 3. KPS >80;

• 4. Having at least one measurable lesions;

• 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney:

Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;

• 6. No serious allergic constitution;

• 7. No other serous diseases that conflicts with the clinical program;

• 8. No other cancer history;

• 9. No serious mental disorder;

• 10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

• 1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);

• 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;

• 3. Active hepatitis B or hepatitis C infection;

• 4. Recent or current use of glucocorticoid or other immunosuppressor;

• 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;

• 6. Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN

• 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

• 8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;