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Clinical Trials in the UK / NCT04404660
Active, not recruiting Phase 1/2

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

NCT04404660 · tracked via the Priya Life Science UK tracker
Sponsor
Autolus Limited
Phase
Phase 1/2
Started
2020-06-03
Last updated
2026-04-08

Condition(s) studied

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Investigational drug(s) / intervention(s)

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).

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
University of California San Diego Health (UCSD) La Jolla California
University of California Davis (UC Davis) Sacramento California
University of California San Francisco (UCSF) San Francisco California
Colorado Blood Cancer Institute (CBCI) Denver Colorado
University of Miami Miami Florida
H Lee Moffitt Cancer Center Tampa Florida
Winship Cancer Institute of Emory University Atlanta Georgia
University of Chicago Chicago Illinois
University of Kansas Kansas City Kansas
University of Maryland Medical Center Baltimore Maryland
Dana-Farber Cancer Institute Boston Massachusetts
Mayo Clinic Rochester Minnesota
Washington University School of Medicine St Louis Missouri
University of Nebraska Omaha Nebraska
Memorial Sloan Kettering Cancer Center New York New York
University of Rochester Rochester New York
Cleveland Clinic Cleveland Ohio
TriStar Centennial Medical Center (SCRI) Nashville Tennessee
Baylor Scott & White Research Institute Dallas Texas
MD Anderson Cancer Center Houston Texas
TTI-Methodist (Texas Transplant Institute) (SCRI) San Antonio Texas
The Medical College of Wisconsin Milwaukee Wisconsin
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
University College London Hospitals NHS Foundation Trust London Greater London
King's College Hospital London Greater London
Manchester Royal Infirmary Hospital Manchester Greater Manchester
Queen Elizabeth University Hospital Glasgow Scotland
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle upon Tyne Tyne and Wear
University Hospitals Birmingham NHS Foundation Trust Birmingham West Midlands
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) Bristol United Kingdom

More Autolus Limited trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04404660 on ClinicalTrials.gov ↗ ← All trials in the UK