At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
AUTO3 (CD19/22 CAR T cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single-Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity Of AUTO3, a CAR T Cell Treatment Targeting CD19 And CD22 in Paediatric And Young Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
In Brief
A Phase 2 clinical trial evaluating AUTO3 (CD19/22 CAR T cells for B Acute Lymphoblastic Leukemia and 3 related conditions. Completed, enrolled 23 participants across 3 sites.
Detailed Summary
The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia, B-cell Acute Lymphoblastic Leukemia
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedSep 2017
Primary CompletionMay 2020
TodayJul 2026
First PostedSep 21, 2017
Enrollment StartJun 26, 2017
Primary CompletionMay 18, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.8 years ago
Interventions
AUTO3 (CD19/22 CAR T cellsbiological
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose.