Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
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.
Known hypersensitivity to any component of the Investigational Medicinal Product (IMP).
Autologous or allogeneic HCT in 3 months prior to IMP administration.
Severe, uncontrolled active infection.
Life expectancy < 6 weeks.
Single group
Autologous CAR19 T lymphocytes
DrugFirst-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL
Incidence of adverse events
Cumulative incidence of IMP-related adverse events (AEs) graded by ASTCT consensus grading criteria for Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) and by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 for other AEs. Toxicities will be followed from the start of Blood Collection or Apheresis until the end of the study.
Assessment of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration
Complete remission ( CR) rate
Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Complete Remission rate
Overall Survival
Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Overall Survival
Quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
CART19 cells in peripheral blood, bone marrow and cerebrospinal fluid
Assessment of quantity and phenotype of CART19 cells in peripheral blood, bone marrow and cerebrospinal fluid using using flow-cytometry
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