This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).
This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR). Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (± 2 days).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).
Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Time frame: Up to 24 months
Phase II - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
Time frame: Up to 24 months
Phase II - Proportion of patients achieving MRD-negative CR by NGS (<1e-4 leukemic cells)
Time frame: Up to 24 months
Phase II - Complete remission rate
Time frame: Up to 24 months
Phase II - Response to AUTO1 treatment measured as duration of remission (DOR)
Time frame: Up to 24 months
Phase II - Response to AUTO1 measured as progression-free survival (PFS).
Time frame: Up to 24 months
Phase II -Response to AUTO1 treatment measured as overall survival (OS)
Time frame: Up to 24 months
Phase II - Frequency and severity of AEs and SAEs
Time frame: Up to 24 months
Phase II - Incidence of severe hypogammaglobulinaemia
Time frame: Up to 24 months
Phase II - Duration of severe hypogammaglobulinaemia
Time frame: Up to 24 months
Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion
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City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Health (UCSD)
La Jolla, California, United States
University of California Davis (UC Davis)
Sacramento, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
...and 24 more locations
Time frame: Up to 24 months