CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 153 enrolled
Drug / intervention
AUTO1biological
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.

Search/NCT04404660
NCT04404660Phase 2Active
CompareCT.gov

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

Autolus Limited·interventional·Posted May 27, 2020·Updated Apr 8, 2026

In Brief

A Phase 2 clinical trial evaluating AUTO1 for Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia. Active but no longer recruiting, targeting 153 participants across 34 sites in 3 countries.

Detailed Summary

This is a Phase 1b/2 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 (r/r) B cell acute lymphoblastic leukemia (ALL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed or Refractory B Cell Acute Lymphoblastic Leukemia
CountriesSpain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Active
202120222023202420252026202720282029
First PostedMay 27, 2020
Enrollment StartJun 3, 2020
Primary CompletionJun 30, 2029
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 6.1 years agoPrimary completion in 3.0 years

Interventions

AUTO1biological

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).