A study to evaluate AUTO1 in adults with Acute Lymphoblastic Leukaemia who have previously been treated and subsequently progressed.

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.

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001937-16-GB

Enrollment

185

Registered

2019-11-22

Start date

2020-02-17

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory B cell acute lymphoblastic leukaemia MedDRA version: 21.0 Level: LLT Classification code 10000844 Term: Acute lymphoblastic leukaemia System Organ Class: 100000004864

Interventions

Product Name: AUTO1 Product Code: AUTO1 Pharmaceutical Form: Dispersion for infusion INN or Proposed INN: n/a CAS Number: n/a Current Sponsor code: AUTO1 Other descriptive name: Autologous enriched T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 or older. 2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1. 3. Relapsed or refractory B-precursor ALL 4. Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed 2 lines of any tyrosine kinase inhibitor (TKI) or 1 line of second-generation TKI, or if TKI therapy is contraindicated. 5. Documentation of CD19 expression on leukaemic blasts 6. Phase Ib: Primary Cohort IA: Presence of =5% blasts in BM at screening. Exploratory Cohort IB: MRD-positive defined as =10^-4 and =65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: 1. Phase Ib (Cohort IA and Cohort IB) and Phase II Cohort IIA only: ALL with isolated EM disease. 2. Diagnosis of Burkitt's leukaemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukaemia lymphoid blast crisis. 3. History or presence of clinically relevant CNS pathology. 4. Presence of CNS-3 disease or CNS-2 disease with neurological changes. 5. Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management. 6. Active or latent Hepatitis B virus or active Hepatitis C virus 7. Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test 9. Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase Ib - To evaluate the safety of AUTO1. Phase II - To evaluate the clinical efficacy of AUTO1.;Secondary Objective: Phase Ib: - To evaluate the feasibility of manufacturing and administering AUTO1. - To evaluate the clinical efficacy of AUTO1 - To evaluate the expansion and persistence of AUTO1 Phase II - To evaluate the clinical efficacy of AUTO1 - To assess the safety and tolerability of AUTO1 - To evaluate the feasibility of manufacturing and administering AUTO1. - To evaluate the expansion and persistence of AUTO1 - To evaluate the duration of B-cell aplasia - To evaluate Patient Reported Outcome and Quality of life assessment - To evaluate health care resource utilisation for the management of AUTO1 related toxicity.;Primary end point(s): Phase Ib: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion. Phase II: Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi].;Timepoint(s) of evaluation of this end point: Up to 4 years	—

Measure

Time frame

Main Objective: Phase Ib - To evaluate the safety of AUTO1. Phase II - To evaluate the clinical efficacy of AUTO1.;Secondary Objective: Phase Ib: - To evaluate the feasibility of manufacturing and administering AUTO1. - To evaluate the clinical efficacy of AUTO1 - To evaluate the expansion and persistence of AUTO1 Phase II - To evaluate the clinical efficacy of AUTO1 - To assess the safety and tolerability of AUTO1 - To evaluate the feasibility of manufacturing and administering AUTO1. - To evaluate the expansion and persistence of AUTO1 - To evaluate the duration of B-cell aplasia - To evaluate Patient Reported Outcome and Quality of life assessment - To evaluate health care resource utilisation for the management of AUTO1 related toxicity.;Primary end point(s): Phase Ib: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion. Phase II: Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi].;Timepoint(s) of evaluation of this end point: Up to 4 years

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Secondary

Measure	Time frame
Secondary end point(s): Phase Ib: - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered as per protocol. - Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi]. - Proportion of patients achieving MRD-negative CR - Detection of CAR T cells measured in the peripheral blood and bone marrow (BM). Phase II: - Duration of response (DoR). - Relapse Free Survival (RFS). - Event Free Survival (EFS). - Progression free survival (PFS). - Overall Survival (OS). - Proportion of patients achieving MRD-negative CR. - Incidence of CD19 negative relapse - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs). - Incidence and duration of severe hypogammaglobulinaemia. - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered. - Detection of CAR T cells measured in the peripheral blood and BM. - Depletion of circulating B cells. - Changes over time in quality of life scores.;Timepoint(s) of evaluation of this end point: Up to 4 years	—

Measure

Time frame

Secondary end point(s): Phase Ib: - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered as per protocol. - Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi]. - Proportion of patients achieving MRD-negative CR - Detection of CAR T cells measured in the peripheral blood and bone marrow (BM). Phase II: - Duration of response (DoR). - Relapse Free Survival (RFS). - Event Free Survival (EFS). - Progression free survival (PFS). - Overall Survival (OS). - Proportion of patients achieving MRD-negative CR. - Incidence of CD19 negative relapse - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs). - Incidence and duration of severe hypogammaglobulinaemia. - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered. - Detection of CAR T cells measured in the peripheral blood and BM. - Depletion of circulating B cells. - Changes over time in quality of life scores.;Timepoint(s) of evaluation of this end point: Up to 4 years

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Countries

Spain, United Kingdom, United States

Contacts

Public ContactProject Manager

Autolus Limited

clinicaltrials@autolus.com+1240801 3849

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026