CD30-positive lymphoproliferative disorders
Conditions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation in the clinical trials and sign the informed consent; 2. To be aged 18 to 70 years male and female; 3. Patients with CD30-positive lymphoproliferative disorders diagnosed by pathology and histology, meet the criteria of autologous hematopoietic stem cell transplantation, and patients are voluntary to accept through infusion of anti-CD30 CAR-T therapy after HSCT; 4. CD30-positive lymphoproliferative disorders: (1) Adult T-cell leukemia/lymphoma; (2) Anaplastic large-cell lymphoma; (3) Angioimmunoblastic T-cell lymphoma; (4) NK/T-cell lymphoma; (5) Peripheral T-cell lymphoma; (6) Enteropathy-associated T cell lymphoma; (7) Burkitt lymphoma; (8) Hodgkin lymphoma; (9) Diffuse large B-cell lymphoma; (9) Diffuse large B-cell lymphoma; (9) Diffuse large B-cell lymphoma; (10) Follicular lymphoma; (11) Primary mediastinal large B-cell lymphoma; (12) Mycosis fungoides; (13) Other CD30-positive lymphoproliferative disorders; 5. Patients suitable to accept auto-HSCT, and meeting any of the following criteria: (1) Present residual disease or progressive disease after main therapy; (2) Relapse after CR1; (3) Patients with high risk factors; (4) Failure to achieve remission or relapse after other cell immunotherapies; (5) Eligible for allo-HSCT, but unable to implement; 6. At least 1 measurable or evaluable lesion; 7. Multiple organ function assessment: Aspartate transaminase-alanine transaminase ratio = 95%; Bilirubin 40%; 8. Without history of accepting anti-cancer therapy, including chemotherapy, radiotherapy, immunotherapy (e.g., immune suppressive drugs treatment) within 2 weeks of lymphocytapheresis; 9. Adequate venous access for apheresis; 10. ECOG score =3 months.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and nursing females; 2. Planning pregnancy within 1 year; 3. Unguaranteed to use effective contraceptive options (condoms or oral contraceptives, etc.) within 1 year after enrollment; 4. Any uncontrollable infection within 4 weeks of enrollment; 5. Active HBV/HCV infection; 6. Human immunodeficiency virus (HIV) infection; 7. Patients with severe autoimmune diseases or congenital immune deficiency; 8. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 9. Participation in an investigational research study within 6 weeks before enrollment; 10. History of accepting systemic steroids treatments (except inhaled corticosteroids) within 4 weeks before enrollment; 11. History of mental disorders; 12. Drug abuse and addiction; 13. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAR-T treatment related AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Progression-free survival;Event-free lifetime;CAR-T Amplification level;CAR-T Amplification level;Time of CAR-T duration;Features of lymphocyte depletion; | — |
Countries
China
Contacts
Public ContactZhou Jianfeng
Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed