cd7 car-t cells in t-cell lymphoma/leukemia

Conditions: T Lymphoblastic Leukemia/Lymphoma

Summary: t-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. cd7 was proved to be widely expressed in t-cell malignant, which makes it a promising therapeutic target. in this study we aim to test the safety and efficacy of cd7 car-t cells in t-cell lymphoma/leukemia.

t-cell lymphoma accounts for 10%\~15% of non-hodgkin lymphoma in china. according to the world health organization (who), t-cell lymphoma was divided into the following subtypes: t-cell, nk cell lymphoma/leukemia. there were two major categories: anterior t-cell tumors and posterior thymic t-cell lymphomas, which originate from lymph nodes, extranodal tissue, or skin; mature or peripheral t-cell lymphomas. generally speaking, the relapse accounts for 50-60% after first-line treatment, while the remission rate with second-line treatment was extremely low. collectively, there was an urgent need for new treatment modalities to improve the clinical outcomes of these patients. cd7 is a transmembrane glycoprotein that plays an important role in t-cell and t-cell/b-cell interactions during early lymphoid development. the expression of cd7 persist from stem to mature t cells. cd7 was proved to be widely expressed in t-cell malignant, which makes it a promising therapeutic target. in this study we aim to testify the safy and efficacy of cd7 car-t cells in t-cell lymphoma/leukemia.

Eligibility criteria:
inclusion criteria: 1. age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited; 2. the subject voluntarily participates in the research and signs the "informed consent" by himself or his legal guardian; 3. according to the national comprehensive cancer network (nccn) t lymphocytic lymphoma (2020.v1)/acute lymphoblastic leukemia (2020. v1) practice guidelines, diagnosed with t-cell lymphoma; 4. meet the diagnostic criteria for relapsed/refractory t-cell lymphoma, including any of the following: 1) failure to obtain cr at the end of induction therapy; 2) patients who have obtained cr have blasts in peripheral blood or bone marrow (proportion \>5%), or extramedullary diseases; 5. have not received antibody therapy within 2 weeks before cell therapy; 6. ecog score of 0-2; 7. the subject has no contraindications to peripheral apheresis; 8. expected survival time of more than 3 months. exclusion criteria: 1. those who have a history of allergy to any of the ingredients in cell products; 2. laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; serum alt or ast greater than 2.5 times the upper limit of normal; blood creatinine≧ 2.0mg/dl; platelet count≦ 10×109/l; 3. patients with cardiac insufficiency who belong to class iii or iv according to the new york cardiology association (nyha) cardiac function grading standards; or echocardiography with left ventricular ejection fraction (lvef) \< 50%; 4. abnormal lung function, blood oxygen saturation under indoor air \< 92%; 5. myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment; 6. grade 3 hypertension with poor control of blood pressure with medication; 7. patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled); 8. previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease; 9. known central nervous system leukemia (cns2 or cns3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; previous cns history but has been effectively controlled to allow enrollment; 10. patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy; 11. presence of uncontrolled, active infection; 12. have previously used any car-t cell product or other genetically modified t cell therapy; 13. live vaccination within 4 weeks prior to enrollment; 14. hiv, hbv, hcv and tppa/rpr infections, and hbv carriers; 15. subject has a history of alcoholism, drug addiction or mental illness; 16. the subject has participated in any other clinical research within 3 months before joining this clinical study; 17. female subjects have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception; 18. there are other circumstances in which the investigator believes that the subject is not suitable for this study.