Relapse or refractory Hematological malignancies
Conditions
Interventions
single arm:NY-ESO-1 TCR-T cell therapy
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients or their legal guardians sign informed consent. 2. The age of 18-80 years old (including 18 and 80 years old) is male / female. The patients with relapsed / refractory malignant hematopathy (including acute myeloid leukemia, malignant lymphoma, multiple myeloma, myelodysplastic syndrome). 3. The patient had the following HLA-A alleles: a0201, a0203, a0205, a0206 and a0207; meanwhile, NY-ESO-1 staining was positive and > 25% staining was found in the bone marrow biopsy of the patient by immunohistochemistry. 4. Patients with measurable or evaluable lesions; 5. The main tissues and organs of the patients were well functioning (1) Liver function: ALT / AST = 95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%; 6. Patients with unobstructed peripheral superficial vein blood flow; 7. Patients with Karnofsky score >= 30.
Exclusion criteria
Exclusion criteria: 1. Women in pregnancy (positive urine / blood pregnancy test) or lactation; 2. Men or women who have pregnancy plans in the past year; 3. Patients who can't 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. HIV infected patients; 6. Patients with primary tumors other than hematologic malignancies were diagnosed by pathology; 7. Patients with serious autoimmune diseases or immunodeficiency diseases; 8. The patient has allergic constitution and is allergic to macromolecular biological drugs such as antibodies or cytokines; 9. Patients participated in other clinical trials within 6 weeks before admission; 10. Systemic use of corticosteroids (except inhaled corticosteroids) within 4 weeks before admission; 11. Patients with mental illness; 12. The patients had drug abuse / addiction; 13. According to the researcher's judgment, the patient has other unsuitable conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactDeng Qi
Tianjin First Central Hospital
Outcome results
None listed