CD30-positive hematalogical malignancies
Conditions
Interventions
treatment group:anti-CD30 CAR-T cells
Sponsors
The First Affiliated Hospital of Nanchang 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. Patients aged 18 to 70 years (including 18 and 70 years old), no gender limit. 3. After pathological and histological examination, it is diagnosed as CD30+ lymphocyte tumor, which is recurrent and refractory. There is currently no effective treatment plan, such as chemotherapy or hematopoietic stem cell transplantation for recurrence; the patient voluntarily chooses Anti-CD30 CAR-T as a rescue treat. 4. CD30+ lymphocyte tumors: (1) Adult T-cell leukemia/lymphoma; (2) Anaplastic large cell lymphoma (ALCL); (3) Angioimmunoblastic T-cell lymphoma (AITL); (4) NK/T-cell lymphoma (NK/T-cell lymphoma); (5) Peripheral T cell lymphoma (PTCL); (6) Enteropathy-associated T cell lymphoma; (7) Burkitt lymphoma; (8) Hodgkin lymphoma (Hodgkin lymphoma); (9) Diffuse large B-cell lymphoma (DLBCL); (10) Other tumors expressing CD30+ lymphocytes (follicular lymphoma, PMBCL, granuloma fungoides, etc.). 5. Subject: (1) There are still residual lesions after the main treatment, and it is not suitable for HSCT (auto/allo-HSCT); (2) Relapse 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's peripheral superficial vein blood flow is smooth, which can meet the needs of intravenous drip. 9. Patients with ECOG score = 3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; 2. Patients who have a conception plan within 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 diseases or immunodeficiency diseases; 8. The patient has allergies and is allergic to antibodies or cytokines and other macromolecular biological drugs; 9. The patient has participated in other clinical trials within 6 weeks before enrollment; 10. Systemic use of hormones (except for patients who use inhaled hormones) within 4 weeks before the patient is enrolled; 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 |
|---|---|
| safety;objective response rate;complete response;progression free survival;event-free survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| CAR-T persistence;CAR-T expansion; | — |
Countries
China
Contacts
Public ContactLi Fei
The First Affiliated Hospital of Nanchang University
Outcome results
None listed