Anti-CD22 CAR-T Cell Therapy Targeting B Cell Malignancies

Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy Targeting CD22 in Treating Patients With B Cell Malignancies

The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.

Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.

Inclusion Criteria:

1. Age: 18-65 years
2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry
3. Refractory or relapsed B cell-acute lymphoblastic leukemia
4. No available curative treatment options (such as hematopoietic stem cell transplantation)
5. Stage III-IV disease
6. Creatinine < 2.5 mg/dl
7. Aspartate transaminase-alanine transaminase ratio < 3x normal
8. Bilirubin < 2.0 mg/dl
9. Karnofsky performance status >= 60
10. Expected survival time > 3 months
11. Adequate venous access for apheresis
12. Ability to understand and provide informed consent

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients requiring T cell immunosuppressive therapy
3. Active central nervous system leukemia
4. Any concurrent active malignancies
5. Patients with a history of a seizure disorder or cardiac disorder
6. Previous treatment with any immunotherapy products
7. Patients with human immunodeficiency virus, hepatitis B or C infection
8. Uncontrolled active infection