B-cell tumor
Conditions
Interventions
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: [1] Age =18 years and =70 years; [2]ECOG score 0-2 and predicted survival greater than 12 weeks; [3] Diagnosed with recurrent and/or refractory B-cell malignancies (including acute B-lymphoblastic leukemia, B-cell lymphoma, plasma cell tumor, etc.); [4] Have measurable or evaluable extramedullary masses or enlarged lymph nodes; [5] The patient's main tissues and organs function well: (1) Liver function: ALT/AST < 3 times the upper limit of normal value (ULN); (2) Renal function: creatinine < 220µmol/L; (3) Lung function: indoor oxygen saturation =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) =40%. [6] Not suitable for hematopoietic stem cell transplantation or give up transplantation due to limitations or relapse after transplantation; [7] Blood can be taken intravenously without other contraindications for leukocyte removal. [8] Patients or their legal guardians voluntarily participate and sign the informed consent.(YNMT)·
Exclusion criteria
Exclusion criteria: [1] Pregnant or lactating women, or women who plan to become pregnant within six months; [2] Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); [3] Feasibility assessment screening demonstrated transfection of targeted lymphocytes < 10% or underamplification (< 5 fold) under CD3/CD28 combined stimulation; [4] Abnormal vital signs and failure to cooperate with tests; [5] Patients with mental or psychological diseases that cannot be treated and evaluated; [6] People who are highly allergic or have a history of severe allergy, especially to IL-2; [7] Subjects with systemic infection or severe local infection requiring anti-infection treatment; [8] Complicated with dysfunction of heart, lung, brain, liver, kidney and other important organs; [9] Doctors believe there are other reasons why people cannot be included in treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Total remission rate;Complete remission rate;Partial remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival ; | — |
Countries
China
Contacts
Public ContactCao Jiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed