Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.

This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10^6 cells per kg body weight.

Inclusion Criteria:

1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
2. No alternative treatment options deemed by investigator.
3. Measurable or detectble disease at time of enrollment.
4. Eastern cooperative oncology group (ECOG) performance status of ≤2.
5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
6. Estimated life expectancy > 12 weeks deemed by investigator.
7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN).
9. Informed consent explained to, understood by and signed by patient/guardian.

Exclusion Criteria:

1. Pregnant or lactating women
2. Uncontrolled infection
3. Active hepatitis B virus or hepatitis C virus infection.
4. Patients who need steroids to control disease.
5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
7. History of Human Immunodeficiency Virus (HIV) infection.
8. Patients with active central nervous system (CNS) involvement by malignancy.
9. Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre.