A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Sponsor: Autolus Limited
ClinicalTrials ID:NCT04404660
This Phase Ib/II open-label study assesses the safety and efficacy of AUTO1 in adults with relapsed/refractory B-cell ALL. Eligible patients, 18+ with specific CD19 positivity and adequate organ function, undergo screening, leukapheresis, pre-conditioning, and receive a split dose of CAR T cells post-chemotherapy. The study evaluates overall response rate.
Patient Parameters
| Parameter | Options |
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Program Overview
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).
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).
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: 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope National Medical Center | 93534 | Duarte | California |
| University of California San Diego Health (UCSD) | 92093 | La Jolla | California |
| University of California Davis (UC Davis) | 95817 | Sacramento | California |
| University of California San Francisco (UCSF) | 94143 | San Francisco | California |
| Colorado Blood Cancer Institute (CBCI) | 80218 | Denver | Colorado |
| University of Miami | 33136 | Miami | Florida |
| H Lee Moffitt Cancer Center | 33612 | Tampa | Florida |
| Winship Cancer Institute of Emory University | 30322 | Atlanta | Georgia |
| University of Chicago | 60637 | Chicago | Illinois |
| University of Kansas | 66160 | Kansas City | Kansas |
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