CD7 positive is refractory to treatment for recurrent malignant hematologic tumors
Conditions
Interventions
Case series:CAR-T cell therapy targeting CD7
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The patient or his legal guardian voluntarily participates and signs an informed consent form; 2. Male or female patients aged 18 to 70 (including 18 and 70 years old); 3. The patient is diagnosed as CD7+ cell tumor by immunophenotyping, pathology and histological examination. The patient currently has no effective treatment plan, such as chemotherapy or hematopoietic stem cell transplantation and recurrence; or the patient voluntarily chooses to infuse anti-CD7 CAR-T cells as Salvage treatment. 4. T cell tumors include the following 4 types: (1) T-cell acute lymphoblastic leukemia (T-ALL); (2) CD7+ lymphoma; (3) CD7+ acute non-lymphocytic leukemia; (4) Other CD7+ lymphomas; 5. Subject: (1) After treatment, there is no remission or residual disease, and it is not suitable for HSCT (auto/allo-HSCT); (2) Recurrence occurs after CR and is not suitable for HSCT (auto/allo-HSCT); (3) Patients with high-risk factors; (4) Relapse or disease without remission after hematopoietic stem cell transplantation or cellular immunotherapy. 6. Have measurable or evaluable lesions; 7. The patient's main tissues and organs function well: (1) Liver function: ALT/AST=95%; (4) Heart function: Left ventricular ejection fraction (LVEF) >=40%; 8. The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before enrollment, and his previous treatment-related toxicity had returned to =3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; 2. Men or women who have a conception plan in the past year; 3. Patients cannot be guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within 1 year after enrollment; 4. The patient had an uncontrollable infection within 4 weeks before enrollment; 5. Active hepatitis B/C virus; 6. HIV infected patients; 7. Suffer from severe autoimmune disease or immunodeficiency disease; 8. The patient has an allergic physique and is allergic to large molecular biological drugs such as antibodies or cytokines; 9. The patient has participated in other clinical trials within 6 weeks before enrollment; 10. Systemic use of hormones (except for patients using inhaled hormones) within 4 weeks before enrollment; 11. Suffer from mental illness; 12. The patient has drug abuse/addiction; 13. According to the judgment of the investigator, the patient has other unsuitable conditions for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RRR;CR; | — |
Countries
China
Contacts
Public ContactKailin Xu
Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed