CD19-positive patients with chemotherapy-tolerant or relapsed B cell Leukemia
Conditions
Interventions
Test group: intensive pretreatment combined with GB5005 chimeric antigen receptor T cell injection
Sponsors
Shanghai Zhaxin Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions must be met for patients to enter the study: 1. Candidates can communicate effectively with researchers and sign informed consent in writing; 2. Age: more than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; 3. Refer to the standard for diagnosis and treatment of lymphoma (2018 Edition), patients with non Hodgkin's lymphoma confirmed by cytology and histology; 4. Patients with positive CD19 expression in tumor cells confirmed by flow cytometry or histopathology; 5. Meet the definition of relapse or refractory at the time of screening: at least have received the second-line or above systemic anti-tumor treatment (including autologous hematopoietic stem cell transplantation) including rituximab (or other CD20 targeted drugs) and anthracycline drugs, and the disease progress (PD) or relapse after the last treatment; or the relapsed patients who do not fully meet the above conditions, but refuse chemotherapy, and strongly require car- T treatment; 6. There is at least one measurable focus: the long axis of the focus in the node is more than 1.5 cm, or the long axis of the focus outside the node is more than 1.0 cm; 7. Patients without evidence of central nervous system lymphoma on brain MRI; 8. Blood routine test: neutrophil >= 1.0 x 109 / L; hemoglobin >= 70 g / L; platelet >= 50 x 10^9 / L; 9. Coagulation function: fibrinogen >= 1 g/L; activated partial thromboplastin time (APTT) = 45%. (the group can be enrolled if it meets the standard after correction treatment); 12. Pulmonary function: dyspnea = 92% in indoor air environment; 13. Patients with ECoG score of 0-2; 14. Patients with expected survival longer than 3 months; 15. Patients with sufficient functional organ level during screening; 16. Female subjects of childbearing age must be tested for serum pregnancy at the time of screening and before receiving pretreatment chemotherapy, and the results are negative. They are willing to use a very effective and reliable method of contraception within one year after using the research treatment; 17. If male subjects have an active sexual life with women with reproductive potential, they must be willing to use a very effective and reliable method of contraception within one year after using the research treatment. In addition, all men were strictly prohibited from donating sperm within one year after receiving the study treatment infusion during the study period.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions cannot be enrolled in this study: 1. Patients with previous allergic history of human albumin and DMSO; 2. Active hepatitis B virus (HBV-DNA positive), hepatitis C virus antibody (HCV-RNA positive) or human immunodeficiency virus (HIV) infection; 3. In the past two years, patients with end organ damage caused by autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or need to systematically apply immunosuppressive or other systemic disease control drugs; 4. Patients with unstable angina, myocardial infarction, coronary angioplasty or obvious heart disease within one year after admission; 5. Patients with uncontrolled mental disorders; 6. Patients with other life-threatening severe organ failure; 7. Patients who participated in other clinical studies within 4 weeks; 8. Patients who had received live vaccination within 4 weeks; 9. Patients with banned drugs: (1) Corticosteroids: corticosteroids (defined as > 20mg / day prednisone or equivalent) in the therapeutic dose used within 7 days before leukocyte collection or 48 hours before administration of gb5005. But the use of physiological substitutes, topical and inhaled steroids is allowed (2) Chemotherapy: rescue chemotherapy including tyrosine kinase inhibitor (TKI) within 1 week before leukocyte collection (3) Donor lymphocyte infusion (DLI) within 4 weeks before leukocyte collection (4) Graft versus host disease (GVHD): received systemic anti GVHD treatment within 3 months before the infusion of gb5005 cells (5) Alemtuzumab was used within 6 months before leukocyte collection, or flurubine or cladribine was used within 3 months (6) Use of checkpoint inhibitors or stimulants before enrollment (except for more than 3 biological half lives) 10. Patients with previous lung injury or hemorrhagic cystitis associated with cyclophosphamide therapy are known; 11. Women who have been pregnant, are preparing for pregnancy during the trial, or are breastfeeding; 12. The subjects judged by the investigator are difficult to complete all the visits or operations required by the study plan (including the follow-up period), or the compliance of participating in the study is insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Initial efficacy;Pharmacokinetic characteristics;Immunogenicity; | — |
Countries
China
Contacts
Public ContactChun Wang
Shanghai Zhaxin Hospital
Outcome results
None listed