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

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    185
  • sponsor
    Autolus Limited
Updated on 13 March 2022

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).

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).

Details
Condition Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Treatment AUTO1
Clinical Study IdentifierNCT04404660
SponsorAutolus Limited
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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