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

Autolus

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Treatments

Biological: AUTO1

Study type

Interventional

Funder types

Industry

Identifiers

NCT04404660

2019-001937-16 (EudraCT Number)

FELIX (AUTO1-AL1)

Details and patient eligibility

About

This is a Phase Ib/II 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 B cell acute lymphoblastic leukemia (ALL).

Full description

This Phase Ib/II, 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 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).

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years or older 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 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

Phase Ib (Cohort IA and Cohort IB) and Phase II (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.