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

  • Interventional
  • Recruiting
  • NCT04404660
Eligibility Details Visit Clinicaltrials.gov

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

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).

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).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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: Primary Cohort IA: Presence of ≥5% blasts in BM at screening

         - Phase Ib: Exploratory Cohort IB: MRD-positive defined as ≥ 1E-4 and <5% blasts in the BM at screening

         - Phase II: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening

         - Phase II: Exploratory Cohort IIB: 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 (Cohort IA and Cohort IB) and Phase II Cohort IIA 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. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.

At a Glance

National Government IDNCT04404660

IRB#IRB20-1969

Lead SponsorAutolus Limited

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting