A Clinical Research of CD30-Targeted CAR-T in Lymphocyte Malignancies

Exclusion Criteria

• •9. Ability to give informed consent.
• •10. Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
• •11. Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
• •12. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
• •1. Evident signs suggesting that patients are potentially allergic to cytokines.
• •2. Frequent infection history and recent infection is uncontrolled.
• •3. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
• •4. Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
• •5. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
• •6. Pregnancy and nursing females.
• •7. HIV infection.
• •8. Active hepatitis B or active hepatitis C.
• •9. Participation in a prior investigational study within 4 weeks prior to enrollment or longer if required by local regulation. Participation in non-therapeutic research studies is allowed.
• •10. Class III/IV cardiovascular disability according to the New York Heart Association Classification.
• •11. Patients with a known history or prior diagnosis of other serious immunologic, malignant or inflammatory disease.