cd147-car t cells for relapsed/refractory t cell non-hodgkin's lymphoma

Conditions: T-cell Non-Hodgkin's Lymphoma

Summary: the safety and preliminary effectiveness of cd147-car t cells in patients with relapsed or refractory t cell non-hodgkin's lymphoma will be investigated in this pioneering study.

cd147 has been demonstrated higher and relatively specific expression on t cell non-hodgkin's lymphoma. preclinical studies have shown that car t cells targeting cd147 antigen can continuously eliminate jurkat t-cell lymphoma in mice and extend survival without severe adverse events including hemolysis. preliminary investigation of cd147-car t cells in solid tumors has started and shown an acceptable safety profile. the safety and preliminary effectiveness of cd147-car t cells in patients with relapsed or refractory t cell non-hodgkin's lymphoma will be investigated in this pioneering study.

Eligibility criteria:
inclusion criteria: * the subject must meet all of the following criteria: 1. 18-65 years old; 2. relapsed or refractory t-nhls, including peripheral t-cell lymphoma, not otherwise specified (ptcl-nos), angioimmunoblastic t-cell lymphoma (aitl), alk-positive alcl, alk-negative image result for anaplastic large cell lymphoma (alcl), enteropathy-related t-cell lymphoma, hepatosplenic t-cell lymphoma, etc.; 3. previously received ≥2 lines of treatment without a complete response; 4. immunohistochemical detection of tumor cells cd147 positive; 5. ecog score 0-2; 6. the collection of mononuclear cells can be performed upon the judgment of the researcher; 7. no contraindications for allogeneic hematopoietic stem cell transplantation (allohct); 8. have donors for allohct; 9. agree for sequential treatment of allohct; 10. without serious organ dysfunction in 2 weeks before car-t infusion: 1. heart: without arrhythmia, lvef≥50%, and without pericardial effusion; without heart failure (nyha class iii or iv) within12 months before car-t infusion; without myocardial infarction within 12 months before car-t infusion; without long-qt syndrome or secondary qt interval prolongation; 2. liver: alt\<2 times the upper limit of normal (uln) and tbil\<1.5 times uln, without active hepatitis; 3. aptt and pt\<1.5 times uln; 4. kidney: serum creatinine \ 50 ml/min; 5. fingertip blood oxygen saturation ≥ 92%. 11. estimated survival ≥ 3 months; 12. 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 ending, and male partners should use condoms; 13. the patient is willing to join this clinical trial and sign an informed consent. exclusion criteria: * anyone who has one or more of the following: 1. a history of other malignancies with a disease-free period \< 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. those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation; 3. patients with bone marrow involvement; 4. those who are allergic to the biological agents in car-t cell product ; 5. pregnant or breastfeeding; 6. active bacterial, fungal or viral infection; 7. receiving systemic hormone therapy 1 week before participating in the clinical trial; 8. have received other gene therapy before; 9. hbv or hcv infection or carrier is 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 cytomegalovirus (cmv), adenovirus (adv), bk virus or human herpesvirus 6 (hhv-6), etc.; 12. central nervous system lymphoma (cnsl) is defined as the presence of ≥5 tumor cells/ ul in cerebrospinal fluid (csf) or mri suggested cnsl; any other cns diseases, such as uncontrolled 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 (radiotherapy, surgery or other treatments); 13. imaging determined lung infection; 14. inappropriate to participate in the trial with investigators' decision.

Keywords: car t cells t-cell non-hodgkin's lymphoma cd147