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

NCT04404660 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: FELIX (AUTO1-AL1)2019-001937-16
• Study Type: interventional
• Target: 153
• Locations: 3 countries
• Sites: 34

Brief 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).

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

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

Outcome Measures

Primary Outcomes (2)

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

  Up to 24 months

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

  Up to 24 months

Secondary Outcomes (9)

• Phase 2 - Proportion of patients achieving MRD-negative CR

  Up to 24 months

• Phase 2 - Complete remission rate

  Up to 24 months

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

  Up to 24 months

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

  Up to 24 months

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

  Up to 24 months

Study Arms (1)

AUTO1

EXPERIMENTAL

Biological: AUTO1

Interventions

AUTO1 BIOLOGICAL

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).

Also known as: Obecabtagene autoleucel (obe-cel)

AUTO1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autolus Limited: lead

Study Sites (34)

City of Hope National Medical Center

Duarte, California, 93534, United States

Location

University of California San Diego Health (UCSD)

La Jolla, California, 92093, United States

Location

University of California Davis (UC Davis)

Sacramento, California, 95817, United States

Location

University of California San Francisco (UCSF)

San Francisco, California, 94143, United States

Location

Colorado Blood Cancer Institute (CBCI)

Denver, Colorado, 80218, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68105, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

TriStar Centennial Medical Center (SCRI)

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

TTI-Methodist (Texas Transplant Institute) (SCRI)

San Antonio, Texas, 78229, United States

Location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Fundacio' Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario La Fé

Valencia, 46026, Spain

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, Greater London, NW1 2PG, United Kingdom

Location

King's College Hospital

London, Greater London, SE5 9RS, United Kingdom

Location

Manchester Royal Infirmary Hospital

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, Scotland, G514TF, United Kingdom

Location

Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2GW, United Kingdom

Location

University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)

Bristol, BS2 8ED, United Kingdom

Location

Related Publications (2)

• 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 Jan 8. doi: 10.3324/haematol.2025.288587. Online ahead of print.

  PMID: 41504229 DERIVED

• 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.

  PMID: 39602653 DERIVED

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 27, 2020
• Study Start: June 3, 2020
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (23); GB (8); ES (3)