Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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 Leukemia, Lymphoid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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: Presence of ≥5% blasts in BM at screening
  • Phase II: Cohort A: Presence of ≥5% blasts in BM at screening
  • Phase II: Cohort B: MRD-positive defined as ≥1E-4 and <5% blasts in the BM at screening
  • Adequate renal, hepatic, pulmonary, and cardiac function

You CAN'T join if...

  • Phase Ib and Phase II Cohort A 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

Locations

  • University of California San Francisco (UCSF) not yet accepting patients
    San Francisco California 94143 United States
  • University of California Davis (UC Davis) not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Autolus Limited
ID
NCT04404660
Phase
Phase 1/2
Study Type
Interventional
Last Updated