High-risk lymphoid malignancies
Conditions
Interventions
High-risk B-lymphocytic lymphoma group:Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T therapy)
High-risk multiple myeloma group:CAR-T therapy
High-risk non-B-cell lymphoma group:CAR-T therapy
Sponsors
Xiangya Bo'ai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary to enroll with signed consent form; 2. Aged 14 to 70 years; 3. The expected survival time is more than 3 months; 4. CD19 positive high-risk lymphoma; 5. High-risk multiple myeloma; 6. CD30 et al positive high-risk non-B-cell-derived lymphoma; 7. The clinical trial values during the screening period meet the following criteria: peripheral blood: (1) WBC >= 3.0 x 10^9/L, lymphocyte count > 0.5 x 10^9/L (growth factor support is allowed, but must not receive supportive treatment within 7 days before laboratory examination); (2) PLT >= 50 x 10^9/L (must have not received blood transfusion support within 7 days before laboratory test); (3) Biochemical indicators (except for subjects with tumor lesions in liver and kidney): TBIL =55%; 9. ECOG score <= 2 points; 10. Female patient within childbearing age must use appropriate contraception during the study, and urea/blood pregnancy test must be negative before and during the study.
Exclusion criteria
Exclusion criteria: 1. Received CAR-T therapy targeting any target; 2. Received any kind of therapy targeting CD19, BCMA or CD30; 3. Nursing female patients; 4. Remaining disease of other malignant tumors, except for the following cases: malignant tumors that have received radical treatment, and no known active disease within >= 3 years before enrollment; or fully treated non-melanoma skin cancer, currently No evidence of disease; 5. Patients with severe psychiatric disorders; 6. Patients with other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that conflict with this study; 7. Patients with allogeneic hematopoietic stem cell transplantation; 8. Subjects with severe cardiovascular disease: (1) New York Heart Association(NYHA) stage III or IV congestive heart failure; (2) Patients with myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment; (3) Clinically significant ventricular arrhythmia, or a history of unexplained syncope, non-vasovagal or not due to dehydration; (4) History of severe non-ischemic cardiomyopathy; 9. Patients with infectious or viral diseases (such as HIV positive, syphilis, hepatitis b or c, etc.); 10. Patients with severe heart, liver, renal insufficiency, diabetes and other diseases, such as organ function in the following abnormalities: (1) Total bilirubin > 1.5 times the upper limit of normal, unless the subject has Gilbert's syndrome; (2) Partial prothrombin time or activated partial thromboplastin time or international normalized ratio > 1.5 times the upper limit of normal in the absence of anticoagulant therapy; 11. Patients who have participated in other clinical studies in the past 3 months or have previously received other gene product treatments; 12. Subjects with known AL subtype amyloidosis; 13. Patients with severe allergic constitution, and there is a contraindication to cyclophosphamide or fludarabine chemotherapy drugs; 14. Feasibility assessment screening to demonstrate transfection of targeted lymphocytes < 10% or insufficient expansion (< 5-fold) under CD3CD28 costimulation; 15. Physicians believes that there are patients who cannot be included for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free-Survival; | — |
Countries
China
Contacts
Public ContactYi Yan
Xiangya Bo'ai Rehabilitation Hospital
Outcome results
None listed