CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies

Korábbi kezelés

• Previous treatment with investigational gene or cell therapy medicine products
• Received non-diagnostic purposes major surgery within the past 4 weeks
• Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
• Use of prohibited drugs:
• Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
• GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion

Más betegség

• Active hepatitis B , hepatitis C or HIV infection
• Uncontrolled active infection
• Any uncontrolled active medical disorder that would preclude participation as outlined.

Laborértékek

• Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion

Egyéb

• Presence of grade 2-4 acute or extensive chronic GVHD
• Participated in any other clinical study within the past 4 weeks
• Pregnancy or breast-feeding women
• Any situation that may increase the risk of the test or interfere with the test results

• Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
• Eastern Cooperative Oncology Group (ECOG) performance status <2
• ALT/ AST <3 x normal
• Bilirubin < 2.0 mg/dl
• Creatinine < 2.5 mg/dl and less than 2.5x normal for age
• LVEF< 45%
• Accept white blood cell collection
• Provide informed consent