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

Phase 1

• Conditions: Relapsed or refractory B cell acute lymphoblastic leukaemia; MedDRA version: 21.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001937-16-GB
• Lead Sponsor: Autolus Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-22
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 185

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 <5% blasts in the BM at screening.
Phase II:
Primary Cohort IIA: Presence of =5% blasts in BM at screening.
Exploratory Cohort IIB: MRD-positive defined as =10^-4 and <5% blasts in the BM at screening or isolated EM disease with the exception of CNS disease at screening.
7. Adequate renal, hepatic, pulmonary, and cardiac function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified