A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
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|ClinicalTrials.gov Identifier: NCT04404660|
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : November 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia||Biological: AUTO1||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 4, 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||April 2024|
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).
- Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion [ Time Frame: Up to 24 months ]
- Phase II - Overall response rate (ORR) defined as best response of complete response (CR) or complete response with incomplete recovery of counts (CRi) occurring at any time after AUTO1 infusion [ Time Frame: Up to 24 months ]
- Phase II - Response to AUTO1 treatment measured as duration of response (DOR) [ Time Frame: Up to 24 months ]
- Phase II - Response to AUTO1 measured as progression-free survival (PFS). [ Time Frame: Up to 24 months ]
- Phase II -Response to AUTO1 treatment measured as overall survival (OS) [ Time Frame: Up to 24 months ]
- Phase II - Frequency and severity of AEs and SAEs [ Time Frame: Up to 24 months ]
- Phase II - Incidence of severe hypogammaglobulinaemia [ Time Frame: Up to 24 months ]
- Phase II - Duration of severe hypogammaglobulinaemia [ Time Frame: Up to 24 months ]
- Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion [ Time Frame: Up to 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404660
|Contact: Autolus Limited||+44 (0)203 911 4385||Clinicaltrials@autolus.com|