Clinical Trials /

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

NCT04404660

Description:

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).

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (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

Clinical Trial IDs

  • ORG STUDY ID: AUTO1-AL1
  • SECONDARY ID: 2019-001937-16
  • NCT ID: NCT04404660

Conditions

  • Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia

Interventions

DrugSynonymsArms
AUTO1AUTO1

Purpose

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).

Detailed 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).
    

Trial Arms

NameTypeDescriptionInterventions
AUTO1Experimental
  • AUTO1

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: 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

        Exclusion Criteria:

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase Ib - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion
Time Frame:Up to 24 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Phase II - Response to AUTO1 treatment measured as duration of response (DOR)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II - Response to AUTO1 measured as progression-free survival (PFS).
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II -Response to AUTO1 treatment measured as overall survival (OS)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II - Frequency and severity of AEs and SAEs
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II - Incidence of severe hypogammaglobulinaemia
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II - Duration of severe hypogammaglobulinaemia
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Phase II - Detection of CAR T cells measured by PCR following AUTO1 infusion
Time Frame:Up to 24 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Autolus Limited

Trial Keywords

  • B cell acute lymphoblastic leukemia
  • Relapsed B cell acute lymphoblastic leukemia
  • Refractory B cell acute lymphoblastic leukemia
  • ALL
  • AUTO1
  • CD19-positive CAR T cell

Last Updated

May 28, 2020