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

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT04404660
Trial Phases:	Phase I Phase II	Protocol IDs:	FELIX (AUTO1-AL1) (primary) AUTO1-AL1 NCI-2020-04370 2019-001937-16
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Autolus Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT04404660

Summary

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).

Objectives

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).

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