CD19-positive hematological malignancies
Conditions
Interventions
Sponsors
The Second People's Hospital of Nanyang
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 14 to 75 years old 2. Eligible Diseases: CD19-positive patients with CD19-positive haematological malignancies who are not in complete remission on second-line treatment for CD19-positive lymphoma, who are not in remission on first-line treatment for CD19-positive lymphoblastic leukaemia, who have persistent MRD on consolidation, and who have a predicted survival of between three months and two years. 3. Expected survival of three months or more 4. meet the following indicators: a. ECOG physical status score 0-2 or KPS score >80 b. WBC = 2.5×109/L , LY = 0.7×109/L, LY% = 15% c. Serum creatinine =2.0mg/dL (176.8µmol/L) d. ALT and AST =2.5 ULN e. Serum total bilirubin =2.0mg/dL (34.2µmol/L)
Exclusion criteria
Exclusion criteria: 1. CD19 negative in patient tumor samples; 2. Transduced positive T lymphocytes < 5% or anti-CD3/CD28 stimulated expansion < 5 times; 3. Pregnant or breastfeeding women (the safety of this treatment for unborn babies is unknown, and the pregnancy status of female participants is assessed as negative serum or urine pregnancy tests within 48 hours before infusion); 4. Active hepatitis B or hepatitis C virus infection; 5. HIV/AIDS infection; 6. Any uncontrolled active infection; 7. Currently using systemic steroid drugs (within 7 days of collection). Recent or current use of inhaled steroids was not excluded; 8. Previously received any gene therapy product treatment; 9. Allergy to immunotherapy and related drugs; 10. Patients with heart disease or poorly controlled hypertension who need treatment; 11. Patients who currently have unstable or active ulcers or gastrointestinal bleeding; 12. Patients who have a history of organ transplantation or are waiting for organ transplantation; 13. Hyponatremia, blood sodium < 125 mmol/L; 14. Baseline blood potassium < 3.5 mmol/L (potassium supplementation can be made before participating in the study to restore blood potassium to above this level); 15. Patients need anticoagulant therapy (such as warfarin or heparin); 16. Radiation therapy within 4 weeks before the start of the study (blood collection); 17. Patients who are participating in other clinical trials; 18. The researchers believe that other reasons are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically efficiency;Incidence of adverse reactions;Security; | — |
Countries
china
Contacts
Public ContactJinxiao Yao
The Second People's Hospital of Nanyang
Outcome results
None listed