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Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaPhase 1/2NCT04404660

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

A Phase 1/2 study testing AUTO1 in people with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, run by Autolus Limited at 34 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AUTO1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
34 sitesin 3 countries
Study dates
3 Jun 2020to 30 Jun 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

34 sites in 3 countries.

34 sites in 3 countries

United States23 sites

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

  • Colorado Blood Cancer Institute (CBCI)

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 93534

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of California San Diego Health (UCSD)

    La Jolla, California, 92093

  • University of Miami

    Miami, Florida, 33136

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • TriStar Centennial Medical Center (SCRI)

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska

    Omaha, Nebraska, 68105

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • University of California Davis (UC Davis)

    Sacramento, California, 95817

  • TTI-Methodist (Texas Transplant Institute) (SCRI)

    San Antonio, Texas, 78229

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • H Lee Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

United Kingdom8 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, West Midlands, B15 2GW

  • University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)

    Bristol, BS2 8ED

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire, CB2 0QQ

  • Queen Elizabeth University Hospital

    Glasgow, Scotland, G514TF

  • University College London Hospitals NHS Foundation Trust

    London, Greater London, NW1 2PG

  • King's College Hospital

    London, Greater London, SE5 9RS

  • Manchester Royal Infirmary Hospital

    Manchester, Greater Manchester, M13 9WL

  • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

Other trials in United Kingdom

Spain3 sites

  • Fundacio' Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario La Fé

    Valencia, 46026

Other trials in Spain

About this study

Official title: 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).

Read the 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).

Being tested
AUTO1
Keywords
B cell acute lymphoblastic leukemia, Relapsed B cell acute lymphoblastic leukemia, Refractory B cell acute lymphoblastic leukemia, ALL, AUTO1, CD19-positive CAR T cell
Medical subject headings
Recurrence, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AUTO1Biological

    Also called Obecabtagene autoleucel (obe-cel)

    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).

Study groups in NCT04404660
Study groupRoleWhat they receive
AUTO1ExperimentalNot described
Receives: Biological: AUTO1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion

    Measured: Up to 24 months

  2. Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC.

    Measured: Up to 24 months

Secondary outcomes (9)

  1. Phase 2 - Proportion of patients achieving MRD-negative CR

    Measured: Up to 24 months

  2. Phase 2 - Complete remission rate

    Measured: Up to 24 months

  3. Phase 2 - Response to AUTO1 treatment measured as duration of remission (DOR)

    Measured: Up to 24 months

  4. Phase 2 - Response to AUTO1 measured as progression-free survival (PFS).

    Measured: Up to 24 months

  5. Phase 2 -Response to AUTO1 treatment measured as overall survival (OS)

    Measured: Up to 24 months

  6. Phase 2 - Frequency and severity of AEs and SAEs

    Measured: Up to 24 months

  7. Phase 2 - Incidence of severe hypogammaglobulinemia

    Measured: Up to 24 months

  8. Phase 2 - Duration of severe hypogammaglobulinemia

    Measured: Up to 24 months

  9. Phase 2 - Detection of CAR T cells measured following AUTO1 infusion

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start3 Jun 2020
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404660
Sponsor's protocol ID
FELIX (AUTO1-AL1)
Other IDs
2019-001937-16, 2019
Status last verified
Apr 2026
First submitted
12 May 2020
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jabbour E, Sandhu KS, Shaughnessy P, Logan AC, Abedi M, Shah BD, Bishop MR, Park JH, DeAngelo DJ, Tholouli E, Yallop D, Chaganti S, Hodby K, Barba P, Guerreiro M, Menne T, Shang J, Lao-Sirieix P, Brugger W, Roddie C. Tumor burden-guided dosing contributes to mitigation of immunotoxicities following treatment with obecabtagene autoleucel in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. Haematologica. 2026 Jun 1;111(6):1999-2010. doi: 10.3324/haematol.2025.288587. Epub 2026 Jan 8.

    PubMed 41504229

  • Roddie C, Sandhu KS, Tholouli E, Logan AC, Shaughnessy P, Barba P, Ghobadi A, Guerreiro M, Yallop D, Abedi M, Pantin JM, Yared JA, Beitinjaneh AM, Chaganti S, Hodby K, Menne T, Arellano ML, Malladi R, Shah BD, Mountjoy L, O'Dwyer KM, Peggs KS, Lao-Sirieix P, Zhang Y, Brugger W, Braendle E, Pule M, Bishop MR, DeAngelo DJ, Park JH, Jabbour E. Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia. N Engl J Med. 2024 Dec 12;391(23):2219-2230. doi: 10.1056/NEJMoa2406526. Epub 2024 Nov 27.

    PubMed 39602653

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AUTO1 in people with Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, run by Autolus Limited at 34 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, United Kingdom, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04404660, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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