Safety, Efficacy and Pharmacokinetics of ThisCART19A in Patients With Refractory or Relapsed B Cell Lymphoma

Inclusion Criteria

• •1. 18 years ≤ age ≤ 65 years.
• •2. Voluntarily sign a documented IRB-approved ICF prior to any screening procedure.
• •3. Patients with histologically confirmed B-cell NHL defined by the World Health Organization (WHO) 2016, including but not limited to diffuse large B-cell lymphoma (DLBCL), follicular lymphoma transferring to DLBCL, mantle cell lymphoma (MCL), follicular lymphoma 3B (FL-3B), original Mediastinal (thymus) large B-cell lymphoma, high-grade B-cell lymphoma and AIDS-associated B-cell lymphoma.
• •4. Prior therapy must have included: Anti-CD20 monoclonal antibody and Anthracycline containing chemotherapy regimen.
• •5. Had available evaluation lesion.
• •6. ECOG(Eastern Cooperative Oncology Group) ≤ 2 or Karnofsky ≥ 60%.
• •7. Serum creatinine≤1.5×ULN or creatinine clearance\>30 mL/min/1.73 m2.
• •8. Alanine aminotransferase(ALT)≤5×ULN(Upper limit of normal) and total bilirubin(TBIL)\<2.0 mg/dL(for patients with Gilbert heald diseases, live involvement and taking atazanavir or indinavir, TBIL\<3.0 mg/dL can be enrolled.)
• •9. Left ventricular ejection fraction(LVEF)≥40%
• •10. Absolute neutrophile counts≥1000/mm3
• •11. Thrombocyte≥30000/mm3
• •12. Total bilirubin(TBIL) ≤ 2.0 mg/dL
• •13. Confirmed Cluster of differentiation(CD)19 positive by biopsy for the patients who received CD19 target therapy before.
• •14. Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
• •15. AIDS Related B Cell Lymphoma :HIV virus loading \< 200 copy/ml and CD4+T cell counts \>200 cells/mm3 within 4 weeks before screening.
• •16. Patients with TBIL≤ 1.5 mg/dL, Aspartate aminotransferase(AST) and ALT ≤ 3×ULN, and hepatitis B virus(HBV) DNA \<2000 IU/ml can be enrolled for HBV positive patients(defined as hepatitis B virus surface antigen(HBsAg) positive and hepatitis B core(HBc)-total positive ) and hepatitis C virus(HCV) positive patients(defined as HCV antibody positive) . Patients with cirrhosis are excluded.
• •17. Hepatitis B core antibody(HBcAb) positive patients enrolled in this trial have to taking anti-HBV drugs during the whole research.