B cell malignancies
Conditions
Interventions
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient or his legal guardian voluntarily participates and signs the informed consent; 2. Male or female patients aged 18 to 70 years old (including 18 and 70 years old); 3. Diagnosed as CD19/CD20/CD22+ B-cell tumor by pathological and histological examination, and there is currently no effective treatment, such as chemotherapy or recurrence after hematopoietic stem cell transplantation; or the patient voluntarily chooses to infuse anti-CD19/CD20/CD22 CAR-T cells as rescue therapy. 4. B cell tumors include the following 3 categories: (1) B-cell acute lymphoblastic leukemia (B-ALL); (2) Aggressive B-cell lymphoma (DLBCL, BL, MCL); (3) Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL); 5. Indications: (1) There are still residual lesions after the main treatment, and are not suitable for HSCT (auto/allo-HSCT); (2) Relapse occurs after CR and is not suitable for HSCT (auto/allo-HSCT); (3) Patients with high risk factors; (4) Relapse or no remission of the disease after hematopoietic stem cell transplantation or cellular immunotherapy. 6. Has measurable or evaluable lesions; 7. The patient's main tissues and organs function well: (1) Liver function: ALT/AST =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%. 8. The patient has not received any anti-cancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 4 weeks before enrollment, and the toxicity related to previous treatment has recovered to =3 months.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women who have pregnancy plans within half a year; 2. Patients with infectious diseases (such as HIV, active tuberculosis, etc.); 3. Patients with active hepatitis B or C infection; 4. Feasibility evaluation and screening showed that the target lymphocyte transfection was less than 10% or the amplification was less than 5 times under the stimulation of CD3 / CD28; 5. The patients with abnormal vital signs and unable to cooperate with the examination; 6. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 7. Patients with high allergic constitution or severe allergic history, especially those allergic to IL-2; 8. Patients who need anti infection treatment for systemic infection or local severe infection; 9. Patients with serious autoimmune diseases; 10. The doctor thinks there are patients who cannot be included in the treatment for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Progression Free Survival;overall survival; | — |
Countries
China
Contacts
Public ContactXu Kailin
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed