CD19-positive B cell malignancy
Conditions
Interventions
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient has not received allogeneic hematopoietic stem cell transplantation (allo-HSCT); 2) Have appropriate allogeneic(HLA-matched or HLA-haploidentical) T cells for the preparation of CAR-T cells; (HLA-matched or HLA-haploidentical donors); 3) Between 5 and 70 years of age; irrespective of gender; 4) patients with CD19 positive lymphoma or leukemia determined by histology (including bone marrow biopsy) or flow cytometry; 5) Patients with relapsed/refractory B-cell leukemia/lymphoma; The definition of recurrence refers to the emergence of new lesions after complete response from the previous treatment. The refractory definition refers to the absence of a valid treatment option and a limited prognosis (only a few months to two years) after the current available treatment intervention; 6) ECOG Performance Status 0-2; 7) have experienced at least one complete combined chemotherapy / targeted therapy; 8) The toxic and side effects of the last treatment should be recovered with an interval of at least 4 weeks from the most recent chemotherapy, and of at least 3 half-lives from the last immunotherapy; 9) with life expectancy above 3 months; 10) white blood cell 4 x 10^9/L - 10x10^9/L, lymphocyte 1.1x10^9/L - 3.2x10^9/L, haemoglobin = 80g/L, PLT = 60x10^9/L; 11) The functioning of important viscera being normal: cardiac ultrasound indicates that cardiac ejection fraction = 50%, and the ECG being not significantly abnormal. The blood oxygen content is = 90%. Creatinine clearance rate (by CG formula) = 60ml/min; ALT and AST 3.0xULN; Serum bilirubin and alkaline phosphatase 2.0xULN; Blood potassium and sodium is normal; Serum lipase and amylase < 1.5 x ULN; Serum Alb = 30 g/L; 12) with adequate intravenous access for a single blood collection or intravenous blood collection, and no other blood cell separation contraindications; 13) Agrees to take active contraceptives measure during and 3 month after the trial; 14) Agrees to the 24-week assessment schedule and follow-up plan and to cooperate actively; 15) The patient or guardian agrees to participate in this clinical trial and sign a written informed consent form prior to the participating in this trial.
Exclusion criteria
Exclusion criteria: 1) Taking immunosuppressive therapy in the past month; 2) With history of other malignancies in the last 5 years (except for cured skin and cervical in situ); 3) Have received or are receiving other investigational drug or other gene therapy or cell therapy; 4) Any woman who has a pregnancy plan during the treatment period with child-bearing potential needs to undergo a serum pregnancy diagnosis within 48 hours prior to cell treatment to exclude pregnancy; 5) Nursing woman; 6) Uncontrollable active infection; 7) Active infection of HBV or HCV; 8) HIV positive; 9) Been using immunosuppressive agents or systemic steroid therapy (except for inhalation therapy); 10) Interstitial lung disease of Grade =2; 11) Clinically severe heart disease (NYHA) of Grade II or more severe congestive heart failure, or severe arrhythmia requiring drug intervention; 12) Uncontrollable hypothyroidism or hyperthyroidism; 13) Suffering from congenital immune deficiency disease or bone marrow deficiency disease; 14) Uncontrollable epilepsy, central nervous system disease, cerebral vascular accident or having history of mental disorders; 15) Poor compliance or with conditions deemed not appropriate to be included in the study by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate, safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| six cytokines, procalcitonin and C-reactive protein, etc.;positive rate of human anti-human mouse chimeric antibody (HACA);The changes in T cell subsets after treatment; | — |
Countries
China
Contacts
Public ContactMingfeng Zhao
Department of hematology, Tianjin First Central Hospital
Outcome results
None listed