Overview
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.
Description
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 0.2-6 x 10^6 cells per kg body weight.
Eligibility
Inclusion Criteria:
- Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
- No alternative treatment options deemed by investigator.
- Measurable or detectble disease at time of enrollment.
- Eastern cooperative oncology group (ECOG) performance status of 2.
- Cardiac ejection fraction 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
- Estimated life expectancy > 12 weeks deemed by investigator.
- Serum creatinine 1.6 mg/dl and/or blood urea nitrogen(BUN) 1.5 mg/dl .
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 upper limit of normal (ULN).
Exclusion Criteria:
- Pregnant or lactating women
- Uncontrolled infection
- Active hepatitis B virus or hepatitis C virus infection.
- Patients who need steroids to control disease.
- Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
- Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
- History of Human Immunodeficiency Virus (HIV) infection.
- Patients with active central nervous system (CNS) involvement by malignancy.
- Patients combine with other disease cause neutrophil count (ANC) < 750 per microlitre or platelet count (PLT)< 50,000 per microlitre.