A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
NCT ID: NCT04404660
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
153 participants
INTERVENTIONAL
2020-06-03
2029-06-30
Brief Summary
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Detailed Description
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Adult patients with relapsed or refractory 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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AUTO1
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening
* Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening
* Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening
* Phase II: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central ClonoSEQ® NGS testing and \<5% blasts in the BM at screening
* Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Autolus Limited
INDUSTRY
Responsible Party
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Locations
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City of Hope National Medical Center
Duarte, California, United States
University of California San Diego Health (UCSD)
La Jolla, California, United States
University of California Davis (UC Davis)
Sacramento, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
Colorado Blood Cancer Institute (CBCI)
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
TriStar Centennial Medical Center (SCRI)
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
TTI-Methodist (Texas Transplant Institute) (SCRI)
San Antonio, Texas, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Fundacio' Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario La Fé
Valencia, , Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom
King's College Hospital
London, Greater London, United Kingdom
Manchester Royal Infirmary Hospital
Manchester, Greater Manchester, United Kingdom
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Bristol, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2019-001937-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FELIX (AUTO1-AL1)
Identifier Type: -
Identifier Source: org_study_id
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