B cell malignancies
Conditions
Interventions
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 5-70 years; 2. The ECOG score 12 weeks; 3. Diagnosis of refractory or recurrent CD79b+B cell malignant hematopathy, including the following three categories: (1) B-cell acute lymphoblastic leukemia (b-all); (2) Inert b-cell lymphoma (CLL, FL, MZL, LPL, HCL); (3) Invasive b-cell lymphoma (DLBCL, BL, MCL) 4. With measurable or evaluable lesions; 5. The main tissues and organs of the patients have good functions: (1) Liver function: ALT/AST =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >=40%; 6. It is not suitable for stem cell transplantation, or the transplantation is abandoned due to restrictions or the recurrence after transplantation; 7. Voluntary car-t treatment for patients with b-cell malignant hematopathy; 8. Blood can be extracted intravenously and there are no other contraindications for leucocyte removal; 9. Patients or their legal guardians voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected or active hepatitis B or hepatitis C infection; 3. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 4. Patients with abnormal vital signs or could not cooperate with inspectors; 5. History of mental disorders; 6. Highly allergic constitution or severe allergies, especially allergic to IL-2; 7. Systemic infection or serious infections should be local anti-infection treatment; 8. With heart, lung, brain, liver, kidney and other important organ dysfunction; 9. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of antibody;Progression Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactJiang Cao
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed