A Phase II Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL
This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.
• Eligible patients with a diagnosis of aggressive NHL:
‣ Patients after progression on at least one standard chemotherapy and one salvage regimen or
⁃ Patients considered for alloSCT but are found ineligible or
⁃ Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.
• Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.
• CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry
• Age \> 18 year up to 75 years old (if deemed fit by treating investigator);
• Baseline absolute CD3+ T cell count by FACS ≥100/µl;
• ECOG performance score of 0-2 at screening;
• No active Hepatitis B, Hepatitis C, HIV I/II
• No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;
• Signed and dated informed consent, before conduct of any trial-specific procedure.