B cell lymphoma
Conditions
Interventions
Low dose:The infusion of 2.0x10^6 CAR+ T Cells/kg (+/-20%)
Intermediate dose:The infusion of 6.0x10^6 CAR+ T Cells/kg (+/-20%)
High dose:The infusion of 1.0x10^7 CAR+ T Cells/kg (+/-20%)
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 to 70 years old; 2. According to the WHO classification standard for lymphocytic tumors (2016), the histologically confirmed patients included: DLBCL (NOS), follicular lymphoma, DLBCL transformed from CLL / SLL, pmbcl and advanced B-cell lymphoma; 3. Patients with R / R B-cell lymphoma (meeting one of the following conditions): (1) Patients who are not relieved or relapsed after receiving second-line or above chemotherapy; (2) Primary drug resistance; (3) Patients with relapse after hematopoietic stem cell transplantation; 4. Patients with at least one assessable tumor focus according to Lugano 2014 standard; 5. Serum total bilirubin =50%; 7. In patients with no active infection of the lung, the indoor air oxygen saturation >=92%; 8. Patients whose estimated survival time is more than 3 months; 9. ECoG score 0-1; 10. The subjects or their legal guardians voluntarily participated in the test and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with extranodal lesions (tumor cells in cerebrospinal fluid and / or invasion of intracranial lymphoma on MRI); 2. Patients with extensive gastrointestinal lymphoma; 3. Patients who have a history of allergy to any component of cell products; 4. Patients who have previously used any car T-cell product or other genetically modified T-cell therapy; 5. Patients who had received radiotherapy, chemotherapy and monoclonal antibody treatment within one week before operation; 6. According to the New York Heart Association (NYHA) heart function grading standard, subjects with grade III or IV cardiac insufficiency; 7. Patients with myocardial infarction, angioplasty or stenting, unstable angina or other serious heart disease within 12 months after admission; 8. Patients with grade 3 or above serious primary or secondary hypertension (who hypertension guidelines, 1999); 9. ECG showed that patients with QT interval prolongation and severe heart disease such as serious arrhythmia had been found before; 10. Patients with previous history of craniocerebral injury, disturbance of consciousness, epilepsy, cerebral vascular ischemia, cerebral vascular hemorrhage and other diseases; 11. Patients with severe active infection (except simple urinary tract infection and bacterial pharyngitis); 12. Patients with indwelling catheters in the body (e.g., percutaneous nephrostomy, Foley catheters, bile duct catheters, or pleura / peritoneum / pericardium catheters). Ommaya reservoir, special central venous catheter such as Port-a-Cath or Hickman catheter is allowed; 13. Subjects with a history of other primary cancers, except: (1) Non melanoma such as basal cell carcinoma of the skin cured by resection; (2) Patients with cervical carcinoma in situ, local prostate cancer and ductal carcinoma in situ with a disease-free survival of more than 2 years after full treatment; 14. Subjects with autoimmune diseases requiring treatment, subjects with immunodeficiency or requiring immunosuppressive therapy; 15. The subjects with live vaccination within 4 weeks before screening; 16. Subjects with a history of alcohol, drug or mental illness; 17. In screening, if the HBsAg of the subjects is positive, the PCR method of active hepatitis B should be used. If the copy number of HBV DNA is more than 1000, it should be excluded. If the copy number of HBV DNA is less than 1000, it needs routine antiviral treatment after entering the group), as well as those infected with hepatitis C, syphilis and HIV; 18. The patients who used systemic steroids within one week before screening (those who used inhaled steroids were not included); 19. Select the subjects who have participated in other clinical trials in the previous two weeks; 20. Pregnant and lactating women and subjects (both men and women) who are fertile and unable to take effective contraceptive measures; 21. Any circumstances that the investigator believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity(DLT);Incidence of treatment-emergent adverse events (TEAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;disease control rate; | — |
Countries
China
Contacts
Public ContactKaiyang Ding
Anhui Provincial Cancer Hospital
Outcome results
None listed