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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

In brief

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).

Key facts

Study ID

NCT04404660

Run by

Autolus Limited

People needed

153

Starts

2020-06-03

Expected to finish

2029-06-30

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.