B-cell malignancies
Conditions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. Aged 18 to 70 years male and female; 3. Patients with CD20 leukemia or lymphoma diagnosed by pathology and histology, and have no effective treatment by now, including patients who are with relapsed disease after chemotherapy or hematopoietic stem cell transplantation (HSC); or patients are voluntary to accept through infusion of anti-CD20 CAR-T cell therapy as the salvage therapy; 4. types of B cell malignancy are included: B cell Acute lymphoblastic leukemia; Indolent B cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B cell lymphoma (DLBCL, BL, MCL); Multiple myeloma; 5. Patients enrolled in are meeting the following criteria: (1) Present residual disease after main therapy but not eligible for HSCT; (2) Relapse after CR1 but not eligible for HSCT; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after HSCT; (5) Patients with measurable lesions; 6. With observable tumor foci; 7. Multiple organ function assessment: Creatinine =95%; Bilirubin 40%; 8. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy(immune suppressive drugs treatment) within 4 weeks of screening. 9. Adequate venous access for apheresis; 10. ECOG score =3 months.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening; 4. Systemic fungal, bacterial, viral, or other infection that is not controlled, at the time of screening; 5. active HBV/HCV infected; 6. any human immunodeficiency virus (HIV) infection; 7. History of accepting systemic steroids treatments within 4 weeks; 8. Allergic to any cytokines or antibodies; 9. Participation in an investigational research study within 6 weeks before enrolled; 10. History of accepting systemic steroids treatments within 4 weeks; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactZhou Jianfeng
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed