CD30+ lymphoproliferative disease
Conditions
Interventions
case group:Anti-CD30 CAR-T
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients or their legal guardians voluntarily participate in and sign the informed consent; 2. Male or female patients aged between 18 and 70 years (including 18 and 70 years); 3. CD30+ lymphoproliferative disease was confirmed by pathological and histological examination, and the patients had no effective treatment before, such as recurrence after chemotherapy or hematopoietic stem cell transplantation; or patients may voluntarily choose anti-cd30 CAR-T as a salvage treatment. 4. CD30+ cell tumors include the following 12 categories: (1) Adult t-cell leukemia/lymphoma; (2) Anaplastic large cell lymphoma (ALCL); (3) Vascular immunoblastic t-cell lymphoma (AITL); (4) NK/ t-cell lymphoma; (5) Peripheral t-cell lymphoma (PTCL); (6) Enteropathy-associated T cell lymphoma; (7) Hodgkin lymphoma; (8) Diffuse large b-cell lymphoma (DLBCL); (9) Follicular lymphoma; (10) Primary mediastinal large b-cell lymphoma; (11) Mycosis fungoides; (12) Other CD30+ lymphoproliferative diseases. 5. Subject: (1) Residual lesions were still found after the main treatment, and HSCT (auto/ allo-hsct) was not suitable for the treatment; (2) Relapse occurred after CR1, and HSCT (auto/ allo-hsct) was not suitable; (3) Patients with high risk factors; (4) After hematopoietic stem cell transplantation or cell immunotherapy, the disease recurred or was not alleviated. 6. With measurable or evaluable lesions; 7. Main tissues and organs of the patient have good functions: (1) Liver function: ALT/AST = 95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%. 8. Those who did not receive any anticancer treatment such as chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) within 4 weeks prior to enrollment, and their toxicity related to previous treatment had recovered to = 3 months.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or lactating; 2. Men or women who have planned to conceive within the past 1 year; 3. Patients who are not guaranteed to take effective contraceptive measures (condoms or contraceptives, etc.) within one year after enrollment; 4. Patients with uncontrollable infectious diseases within 4 weeks before enrollment; 5. Patients with active hepatitis B / C; 6. With HIV infected patients; 7. With severe autoimmune disease or immunodeficiency disease; 8. Patients with allergic constitution, allergic to macromolecular biological drugs such as antibodies or cytokines; 9. Patients who participated in other clinical trials within 6 weeks before enrollment; 10. Patients who systematically used hormone (except those who used inhaled hormone) within 4 weeks before enrollment; 11. Patients with mental illness; 12. Patients with substance abuse / addiction; 13. Patients with other unsuitable conditions judged by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety index;Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, CR and PR;PFS;EFS; | — |
Countries
China
Contacts
Public ContactHu Kai
Beijing Boren Hospital
Outcome results
None listed