Lymphoma
Conditions
Keywords
lymphoma CAR-T
Brief summary
The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.
Detailed description
The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.
Interventions
BIOLOGICALCD19-targeted CAR-T cells
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..
Sponsors
Sinobioway Cell Therapy Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age is 16 years old, less than 70 years old, sex is not limited, race is not limited; 2. The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation; 3. The patient needs to have a lesion that can be used to detect or evaluate the disease. 4. 0\ 1 score of physical status score of the eastern cancer cooperation group (ECOG). 5. At the time of collection of peripheral white blood cell counts over 1 \* 10\^9/L; 6. Expected survival time \> 90 days; 7. Patients have the ability to know and sign informed consent.
Exclusion criteria
1. Pregnant or lactating women; 2. Uncontrolled infection; 3. HIV infected people, hepatitis B or HCV active stage; 4. Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.). 5. Combined with active central nervous system malignant tumor invading; 6. Has abnormal coagulation function, and there are patients with serious thrombus. 7. Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system. 8. Patients who participated in other clinical trials in the past 30 days or in other clinical trials; 9. Researchers believe that patients are not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure: The overall efficiency | [Time Frame: 3 years] | Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated |
Countries
China
Contacts
Primary ContactGuolin Wu
Backup ContactKaiyang Ding
Outcome results
None listed