Spots Global Cancer Trial Database for CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: CART19 Cells Effects in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

Official Title: 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.

Study ID: NCT05054257

Conditions

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Non-Hodgkin's Lymphoma Refractory

Non-Hodgkin's Lymphoma, Relapsed

Interventions

Autologous CAR19 T lymphocytes

Study Description

Brief Summary: Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.

Detailed Description: This is an open-label, single arm study on up to 24 adult subjects with refractory or relapsed CD19+ Non-Hodgkin's Lymphoma or B-ALL. Following lymphodepleting conditioning regimen, the patients will receive a single dose of autologous CAR19 T lymphocytes provided by the sponsor´s manufacturing facility. CART19 dose will be escalated in consecutive patients using accelerated titration design in order to establish recommended CART19 dose for further study, which will be either Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD), whichever is reached first.