lymphoproliferative diseases
Conditions
Interventions
experimental group:anti-CD30 CAR T combined with PD-1 inhibitors
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for relapsed/refractory/high-risk CD30+ lymphoproliferative disease: have been treated with at least 2 chemotherapy regimens previously; the interval between the last chemotherapy and disease progression is less than 1 year; not suitable for hematopoietic stem cell transplantation or due to limitations Abandon hematopoietic stem cell transplantation. 2. Aged 12 to 75 years; 3. The expected survival period is 6 months to 2 years; 4. Using the Eastern Cooperative Oncology Group (ECOG) scale score = 1.0 x 10^9/L; platelet count (PLT) >= 50 x 10^9/L; hemoglobin concentration >= 7.0 g/dL; (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 mL/min (using the standard Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR) <= 1.5 x ULN; activated partial thromboplastin time (APTT) <= upper limit of normal 10s; (5) Thyroid-stimulating hormone (TSH) is within the normal range; if TSH is abnormal, free triiodothyronine (FT3) and free thyroxine (FT4) must be within the normal range, and thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb), thyroid stimulating hormone receptor antibody (TRAb) were all negative; 6. Women of childbearing age have a negative urine pregnancy test before the start of administration. During the study period and within 6 months after the end of administration, subjects with reproductive potential (regardless of men and women) must take effective medical contraceptive measures (for specific contraceptive measures, see Annex 5); 7. Written informed consent can be provided.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons; 3. Those who are known to be allergic to the components of the test drug; 4. Patients with grade 3 or higher neurotoxicity within two weeks before treatment; 5. Combined with severe infection; 6. Those who are deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;progression-free survival;duration of remission;time to remission; | — |
Countries
China
Contacts
Public ContactSang Wei
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed