Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSD UCSF
Dates
study started
completion around

Description

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).

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

Details

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).

Keywords

Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, B cell acute lymphoblastic leukemia, Relapsed B cell acute lymphoblastic leukemia, Refractory B cell acute lymphoblastic leukemia, ALL, AUTO1, CD19-positive CAR T cell, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoid Leukemia

Eligibility

Locations

  • University of California San Diego Health (UCSD)
    La Jolla California 92093 United States
  • University of California Davis (UC Davis)
    Sacramento California 95817 United States
  • University of California San Francisco (UCSF)
    San Francisco California 94143 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Autolus Limited
ID
NCT04404660
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 153 people participating
Last Updated