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

Status
Closed
Cancer Type
Hematopoietic Malignancies
Leukemia
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04404660
Protocol IDs
FELIX (AUTO1-AL1) (primary)
AUTO1-AL1
NCI-2020-04370
2019-001937-16
Study Sponsor
Autolus Limited

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).

Objectives

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).

Eligibility

  1. Age 18 years or older Age 18 years or older
  2. ECOG performance status of 0 or 1
  3. Relapsed or refractory B cell ALL
  4. 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
  5. Documented CD19 positivity within 1 month of screening
  6. Phase Ib: Primary Cohort IA: Presence of =5% blasts in BM at screening
  7. Phase Ib: Exploratory Cohort IB: MRD-positive defined as = 1e-4 and <5% blasts in the BM at screening
  8. Phase II: Primary Cohort IIA: Presence of =5% blasts in BM at screening
  9. Phase II: Cohort IIB: =2nd CR or CRi with MRD-positive defined as =1e-3 by central ClonoSEQ® NGS testing and <5% blasts in the BM at screening
  10. Adequate renal, hepatic, pulmonary, and cardiac function
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