T cell non-Hodgkin lymphoma
Conditions
Interventions
CD147-CART treatment group:Autologous CD147-CART cells
Sponsors
National Translational Science Center for Molecular Medicine, Air Force Medical University of PLA
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-65 years; 2. Relapsed or refractory T-NHLs during screening: including PTCL-NOS, AITL, ALK-positive ALCL, ALK-negative ALCL, enteropathy-related T-cell lymphoma, hepatosplenic T-cell lymphoma, etc.; 3. Previously received >=2 lines of treatment, and the disease has not reached a complete response; 4. CD147 positive by immunohistochemical detection of tumor cells; 5. ECOG score 0-2; 6. The venous access required for collection can be established, and the collection of mononuclear cells can be performed upon the judgment of the researcher; 7. Have donors for allogeneic hematopoietic stem cell transplantation; 8. Consent to sequential radical treatment of allogeneic hematopoietic stem cell transplantation; 9. No serious organ dysfunction within 2 weeks before treatment: (1) Heart: no arrhythmia, LVEF>=50% and no pericardial effusion; no cardiac insufficiency (NYHA III or IV) 12 months before treatment; no myocardial infarction in 12 months before treatment; no long QT syndrome or secondary QT interval prolongation; (2) Liver: ALT 50 ml/min; (5) Indoor fingertip blood oxygen saturation >= 92%. 10. Estimated survival time >= 3 months; 11. Sexually active patients must be willing to use an effective method of birth control during the study period and within 6 months after the study ends, and male partners should use condoms; 12. The patient wishes to join this clinical trial and signs an informed consent.
Exclusion criteria
Exclusion criteria: 1. A history of other malignant tumors with a disease-free period of less than 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection); 2. Have received an organ transplant; 3. Patients with bone marrow involvement; 4. Patients are allergic to the biological agents used in this treatment; 5. Pregnancy or breastfeeding; 6. Active bacterial, fungal or viral infection; 7. Being receiving systemic hormone therapy one week before entering the clinical trial; 8. Have received other gene therapy before; 9. HBV or HCV infection or carrying, defined as: HBsAg positive or HBV-DNA positive; anti-HCV positive and HCV-RNA positive; 10. Active HIV infection; 11. Clinical diagnosis of virus infection or uncontrolled virus activation, including CMV, Adv, BK or HHV-6, etc.; 12. Central nervous system (CNS) diseases: CNS lymphoma (CNSL) is defined as the presence of >=5tumor cells per square millimeter of cerebrospinal fluid (CSF) or MRI suggests CNSL; any other CNS diseases, such as inability Controlled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease involving the central nervous system, or received treatment for central nervous system or brain metastasis within 3 months prior to screening (radiotherapy, surgical treatment or Other treatments); 13. Patients with lung infection determined by imaging examinations; 14. Patients are inappropriate to participate in this trial upon the judgment of the researcher; 15. Contraindications for allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Duration of response;Evaluation of imaging efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate; | — |
Countries
China
Contacts
Public ContactChen Zhinan
National Translational Science Center for Molecular Medicine of Air Force Medical University of PLA
Outcome results
None listed