Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
• Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
‣ B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR
⁃ B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR
⁃ B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT).
• CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.
• Age ≥18 years and ≤ 80 yearss.
• Patient able to understand and sign informed consent.
• Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.