lymphoma
Conditions
Interventions
EBV-CTL:EBV-CTLinfusion
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. lymphoma patients with EB virus positive tumor tissue confirmed by pathology; 2. exclusion of lymphoma leukemia by bone marrow morphology or molecular level; 3. after at least two systematic treatments, the disease status was assessed as relapsed and refractory with measurable lesions. 4. measurable focus definition: (1) lesions with at least one diameter line that can be accurately measured. (2) according to CT or MRI evaluation, the longest diameter of the lesion is at least 10 mm (2 layers thick, 5-8 mm thick). (3) according to the chest X-ray evaluation, the longest diameter of the lesion was at least 20 mm. (4) according to the evaluation of the caliper, the superficial lesions with the longest diameter >= 10 mm. (5) malignant lymph nodes: the pathology is enlarged and measurable. The short CT scanning diameter of a single lymph node must be >= 15mm (the thickness of CT scanning layer is recommended to be no more than 5mm). 4. aged 18-65 years; 5. expected lifetime greater than 6 months; 6. liver and kidney function: bilirubin <= 35 µ mol / L, AST / ALT under 2 times of the upper limit of normal value, blood muscle liver <= 150 µ mol / L; 7. physical condition score 0-2; 8. if the subject is a woman of childbearing age, the pregnancy test is negative before the start of the clinical trial, and it is agreed to take effective contraceptive measures during the study until the last follow-up. 9. obtain informed consent signed by the patient or family member.
Exclusion criteria
Exclusion criteria: 1. treatment related lymphoma; 2. allergic to any drug involved in the program; 3. there are obvious taboos to the research drug and treatment plan; 4. people with a history of epilepsy or other central nervous system diseases; 5. those who have graft-versus-host response and need to use immunosuppressants; 6. peripheral blood leukocyte count < 3 * 10^9 / L; 7. severe heart disease, including myocardial infarction within 6 months, moderate to severe cardiac insufficiency (according to NYHA, a functional aircraft method of the New York Heart Association). 8. at the same time, they have other organ malignant tumors. 9. active stage, active hepatitis B, hepatitis C and HIV positive patients with tuberculosis. 10. untreated active infections. 11. those who used systemic steroids within 2 weeks before the treatment (except those who used inhaled steroids recently or currently). 12. have other blood system diseases at the same time. 13. pregnant or lactating women. 14. previous history of intolerance or allergy to similar drugs. 15. patients who have participated in other clinical researchers and any previous gene therapy or cell therapy at the same time 16. unable to understand or follow the research plan. Any circumstances that the investigator believes may increase the risk of the subject or interfere with the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progress-free survival; | — |
Countries
China
Contacts
Public ContactJunmin Li
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed