A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

April 2, 2026 updated by: Autolus Limited

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This Phase 1b/2, 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 r/r 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

Enrollment (Actual)

153

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Fundacio' Hospital Universitari Vall d'Hebron
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
  • United Kingdom
      • Bristol, United Kingdom, BS2 8ED
        • University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, Greater London, United Kingdom, NW1 2PG
        • University College London Hospitals NHS Foundation Trust
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary Hospital
    • Scotland
      • Glasgow, Scotland, United Kingdom, G514TF
        • Queen Elizabeth University Hospital
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
        • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2GW
        • University Hospitals Birmingham NHS Foundation Trust
  • United States
    • California
      • Duarte, California, United States, 93534
        • City of Hope National Medical Center
      • La Jolla, California, United States, 92093
        • University of California San Diego Health (UCSD)
      • Sacramento, California, United States, 95817
        • University of California Davis (UC Davis)
      • San Francisco, California, United States, 94143
        • University of California San Francisco (UCSF)
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute (CBCI)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • University of Nebraska
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical Center (SCRI)
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • Md Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • TTI-Methodist (Texas Transplant Institute) (SCRI)
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • The Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • ECOG performance status of 0 or 1
  • Relapsed or refractory B cell ALL
  • Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated
  • Documented CD19 positivity within 1 month of screening
  • Phase 1b: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
  • Phase 1b: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and <5% blasts in the BM at screening
  • Phase 2: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
  • Phase 2: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central NGS testing and <5% blasts in the BM at screening
  • Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion Criteria:

  • Phase 1b (Cohort IA and Cohort IB) and Phase 2 (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease
  • Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis
  • History or presence of clinically relevant CNS pathology
  • Presence of CNS-3 disease or CNS-2 disease with neurological changes
  • Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management
  • Active or latent Hepatitis B virus or active Hepatitis C virus
  • Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
  • Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AUTO1
Biological: AUTO1
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).
Other Names:
  • Obecabtagene autoleucel (obe-cel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Phase 2 - Proportion of patients achieving MRD-negative CR
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Complete remission rate
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Response to AUTO1 treatment measured as duration of remission (DOR)
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Response to AUTO1 measured as progression-free survival (PFS).
Time Frame: Up to 24 months
Up to 24 months
Phase 2 -Response to AUTO1 treatment measured as overall survival (OS)
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Frequency and severity of AEs and SAEs
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Incidence of severe hypogammaglobulinemia
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Duration of severe hypogammaglobulinemia
Time Frame: Up to 24 months
Up to 24 months
Phase 2 - Detection of CAR T cells measured following AUTO1 infusion
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autolus Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2020

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FELIX (AUTO1-AL1)
  • 2019-001937-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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