An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: I/II (Cancer Control)
Principal Investigator: Gundabolu, Krishna
Eligibility: https://clinicaltrials.gov/study/NCT04404660?term=NCT04404660&rank=1
Summary
Primary Objectives:
Phase 1b Primary Objective: To evaluate the safety of AUTO1: Endpoint-Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion.
Phase II Primary Objective: To evaluate the clinical efficacy of AUTO1. Endpoint-Overall response rate (ORR) defined as proportion of patients achieving complete response (CR) or complete response with incomplete recovery of counts (CRi) as assessed by an Independent Response Review Committee (IRRC).
Secondary Objectives:
Phase Ib: To evaluate the feasibility of manufacturing and administering AUTO1. Endpoint-Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered as per protocol.
Phase Ib: To evaluate the clinical efficacy of AUTO1. Endpoint-ORR defined as proportion of patients achieving CR or CRi. Proportion of patients achieving MRD-negative CR in BM by polymerase chain reaction (PCR) and/or flow cytometry.
Phase Ib: To evaluate the expansion and persistence of AUTO1.Endpoint-Detection of CAR T cells measured by PCR in the peripheral blood and BM following AUTO1 infusion.
Phase II: To evaluate the clinical efficacy of AUTO1. Endpoints- Duration of response (DoR). Relapse free survival (RFS). Event free survival (EFS). Progression free survival (PFS)
Overall survival (OS). ORR [CR+CRi] as assessed by the Investigator. Proportion of patients achieving MRD-negative CR in BM by PCR and/or flow cytometry. Proportion of patient undergoing stem cell transplantation prior to leukemia relapse. Proportion of patients in CR/CRi without stem cell transplants or other subsequent therapies at 6, 12 and 24 months following AUTO1 infusion. Incidence of CD19 negative relapse.
Phase II: To assess the safety and tolerability of AUTO1. Endpoints - To evaluate the feasibility of manufacturing and administering AUTO1.
Phase II: To evaluate the feasibility of manufacturing and administering AUTO1. Endpoints- Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered.
Phase II: To evaluate the expansion and persistence of AUTO1. Endpoint-Detection of CAR T cells measured by PCR in the peripheral blood and BM following AUTO1 infusion.
Phase II: To evaluate the duration of B cell aplasia.Endpoint-Depletion of circulating B cells assessed by flow cytometry in the peripheral blood.
Phase II: To evaluate Patient Reported Outcome and Quality of life (QoL). Endpoint-Changes over time in symptom, functioning and quality of life scores of the EQ-5D and the EORTC instruments.
Phase II: To evaluate health care resource utilization for the management of AUTO1 related toxicity. Endpoint-Frequency and duration of hospitalisation and/or critical care support to manage AUTO1 related toxicity.