Status:
ACTIVE_NOT_RECRUITING
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Lead Sponsor:
Autolus Limited
Conditions:
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 c...
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). ...
Eligibility Criteria
Inclusion
- 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: 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
- Adequate renal, hepatic, pulmonary, and cardiac function
Exclusion
- Phase Ib (Cohort IA and Cohort IB) and Phase II (Cohort IIA and Cohort IIB) B-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.
Key Trial Info
Start Date :
June 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2029
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT04404660
Start Date
June 3 2020
End Date
June 30 2029
Last Update
September 9 2025
Active Locations (34)
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1
City of Hope National Medical Center
Duarte, California, United States, 93534
2
University of California San Diego Health (UCSD)
La Jolla, California, United States, 92093
3
University of California Davis (UC Davis)
Sacramento, California, United States, 95817
4
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143