Description:
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).
Title
- Brief Title: A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
- Official Title: An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
Clinical Trial IDs
- ORG STUDY ID:
AUTO1-AL1
- SECONDARY ID:
2019-001937-16
- NCT ID:
NCT04404660
Conditions
- Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Interventions
Drug | Synonyms | Arms |
---|
AUTO1 | | AUTO1 |
Purpose
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).
Detailed 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).
Trial Arms
Name | Type | Description | Interventions |
---|
AUTO1 | Experimental | | |
Eligibility Criteria
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: Exploratory Cohort IIB: MRD-positive defined as ≥1E-4 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 only 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Phase II - Response to AUTO1 treatment measured as duration of response (DOR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II - Response to AUTO1 measured as progression-free survival (PFS). |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II -Response to AUTO1 treatment measured as overall survival (OS) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II - Frequency and severity of AEs and SAEs |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II - Incidence of severe hypogammaglobulinaemia |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II - Duration of severe hypogammaglobulinaemia |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Measure: | Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Autolus Limited |
Trial 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
Last Updated
April 15, 2021