Relapsed/refractory EBV positive lymphoma
Conditions
Interventions
Lymphoma group:EBV CAR-T cell
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form; 2. Aged 18-70 years, no gender limit; 3. Estimated survival period >= 3 months; 4. The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0-2; 5. EBV positive lymphoma (NK/T or T cell lymphoma, angioimmunoblastic T cell lymphoma, etc.) is diagnosed by EBERs (EBER-ISH) detected by in situ hybridization technology; 6. Pathological wax section (within 1 year after receiving the diagnosis) or biopsy tissue specimen test: gp350 test is positive; 7. According to the Lugano efficacy evaluation criteria, the subject has at least one measurable lesion; 8. Patients with relapsed/refractory lymphoma who have previously received second-line or above single-drug or combination therapy failure or intolerance; 9. Venous access for apheresis or venous blood collection can be established, and there are no other contraindications for blood cell separation; 10. Has sufficient liver, kidney and blood coagulation functions, defined as follows: (1) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =50 mL/min; (3) Coagulation function: International normalized ratio (INR) <= 1.5 x ULN and activated partial thromboplastin time (APTT) <= 1.5 x ULN; 11. Toxic and side effects caused by early anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, etc.) <= Grade 1 (CTCAE 5.0); 12. During the study period and within 6 months after the end of the administration, subjects with fertility (regardless of male and female) must take effective medical contraceptive measures. Female subjects of childbearing age must undergo a pregnancy test within 72 hours before the first dose, and the result is negative.
Exclusion criteria
Exclusion criteria: 1. Patients with NK/T cell lymphoma with hematopoietic syndrome; 2. There are active central nervous system metastatic lymphomas (except those that are stable after treatment); 3. HIV positive or Treponema pallidum positive, HBsAg positive and HBV DNA copy number positive (quantitative detection >= 1000cps/ml), HCV antibody positive and HCV RNA positive; 4. Subjects with mental or mental illnesses who cannot cooperate with treatment and efficacy evaluation; 5. Subjects with severe autoimmune diseases and subjects with long-term use of immunosuppressive agents; 6. In the 14 days before enrollment, there are active infections or uncontrollable infections that require systemic treatment; 7. Any unstable systemic disease (including but not limited to): unstable angina; cerebral vascular ischemia or cerebrovascular accident (within 6 months before screening); myocardial infarction (within 6 months before screening); congestion congestive heart failure (New York Heart Association [NYHA] classification (see Appendix 4) >= Grade III); severe arrhythmia requiring medical treatment; heart disease requiring treatment or hypertension out of control after treatment (blood pressure > 160 mmHg/100 mmHg)); 8. Combined with dysfunction of lung, brain, kidney and other important organs; 9. The subject has undergone major surgery or severe trauma within 4 weeks before receiving cell therapy, or is expected to undergo major surgery during the study period. 10. The subject received the last radiotherapy or anti-tumor therapy (chemotherapy, targeted therapy or immunotherapy) within 4 weeks before receiving cell therapy 11. The subject currently suffers from or has suffered from other malignant tumors that cannot be cured within 3 years, except for cervical cancer in situ or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival period of more than 5 years; 12. Received treatment with chimeric antigen receptor modified T cells (including CAR-T, TCR-T) within six months; 13. Combined graft versus host disease (GVHD); 4. Subjects who are receiving systemic steroid therapy before screening and the investigator determines that they need long-term use of systemic steroid therapy during the treatment period (except for inhaled or topical use); and subjects treated with systemic steroids within 72 hours before cell reinfusion (except for inhaled or topical use); 15. Severe allergy or history of allergy; 16. Subjects who need anticoagulation therapy; 17. Pregnant or lactating women; 18. The investigator believes that there are other reasons that cannot be included in the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity;Maximum tolerable dose;EBV CAR-T cells expand and continue in the body;Objective response rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactCao Jiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed