recurrent/refractory hematologic tumors
Conditions
Interventions
immune cell treatment group:immune cell injection
Sponsors
Jingzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 69 Years
Inclusion criteria
Inclusion criteria: Patients enrolled in this study must meet all the following conditions: 1. The guardian can communicate effectively with the researcher and sign the informed consent; 2. Age: at least 18 years old and equal or lesser than 69 years old, regardless of gender; 3. Hematological tumors confirmed by cytology and histology, including B-cell acute lymphoblastic leukemia, non-Hodgkin's B-cell lymphoma, multiple myeloma, etc; 4. If CD19/BCMA/EBV is positive confirmed by test, the test results within 3 months before enrollment should be provided; 5. It must meet the definition of relapse or refractory during screening A. There is no remission after at least two induced chemotherapy, and no appropriate targeted drug or targeted therapy is ineffective; B. No remission in induction after BM recurrence; C. First non-advanced (CCR<36 months) BM relapse and no suitable donor (non-related allo-SCT); D. Two or more BM relapses and no suitable donor (non-related allogeneic hematopoietic stem cell transplantation); E. BM recurrence after transplantation; F. Relapsed patients who do not completely meet the above conditions, their gardians refuse chemotherapy and strongly demand CART treatment; 6. After allogeneic hematopoietic stem cell transplantation, patients should stop all immunosuppressive agents for more than 1 month after transplantation and have no aGvHD with activity degree II or higher; 7. Prothrombin time (PT) and thromboactive-enzyme time (PTT) < 2.0 times the upper limit of the normal range; 8. Liver and kidney function indicators: total bilirubin =1.5 times the upper limit of the normal range (except for Gilbert syndrome or hemolysis), ALT and AST =3.0 times the upper limit of the normal range (ULN), serum creatinine =2.0 times the upper limit of the normal range.The above abnormalities may be excluded if they are considered to be caused by tumor infiltration; 9. Left ventricular ejection fraction (LVEF) =45% was assessed by echocardiography (ECHO) or radionuclide active angiography (MUGA).(Can be enrolled into the group if the standard is met after corrective treatment); 10. Lung function: Dyspnea = CTCAE level 1 and SaO2= 92% in indoor air environment; Expected survival is greater than 3 months.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions should not be enrolled in this study: 1. Patients with a history of blood albumin and DMSO allergy; 2.3 Previous history of other malignant neoplasms, except carcinoma in situ (e.g. skin, cervix); 3. Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive) or human immunodeficiency virus (HIV) infection; 4. Active infections that are not adequately controlled: systemic fungi, bacteria, viruses or other infections; 5. In the past 2 years, end organ damage due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the need for systematic application of immunosuppression or other systemic disease control drugs; 6. Active or previous history of CNSL, or other central nervous system diseases of clinical significance, such as epilepsy, palsy, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.Note: Patients with CNS disease under effective control are eligible for inclusion. 7. Uncontrolled mental disorders; 8. Combined with other life-threatening severe organ failure; 9.Participated in other clinical studies within 4 weeks; 10. Previous experience of CAR-T cell or other gene modified T cell therapy; 11. Received live vaccine within 4 weeks of enrollment; 12. Use of prohibited drugs: a. Hormones: corticosteroids (defined as >20mg/ day prednisone or equivalent) that have been administered at therapeutic doses within 7 days prior to collection of peripheral blood stem cells or within 72 hours prior to administration of immune cell injection.However, the use of physiologic substitutes, topical and inhaled steroids is permitted b. Chemotherapy: salvage chemotherapy, including tyrosine kinase inhibitors (TKI), was administered within 1 week before peripheral blood stem cell collection. c. Donor lymphocyte infusion (DLI) received within 4 weeks before peripheral blood stem cell collection d. Graft versus host disease (GvHD) treatment: systemic antiGVHD treatment was received within 3 months prior to cell infusion of immune cell injection e. Use of alemtuzumab in the 6 months prior to collection of peripheral blood stem cells, or use of clofarabine or clarabine in the 3 months prior to collection of peripheral blood stem cells f. Use of checkpoint inhibitors or stimulants before enrollment (except for more than 3 biological half-lives) 13. Patients with lung injury or hemorrhagic cystitis associated with cyclophosphamide treatment are known to have previously occurred; 14. Subjects judged by the investigator to be difficult to complete all visits or procedures required by the study protocol (including the follow-up period), or with insufficient compliance to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactZhiping Huang
Outcome results
None listed