Clinical Trial: NCT04404660
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Autolus Limited |
| Information Provided By: | Autolus Limited |
| Last Update Posted: | 2026-04-08 |
Study Overview
Brief Summary
This is a Phase 1b/2 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 (r/r) B cell acute lymphoblastic leukemia (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
Conditions
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Intervention / Treatment
- Biological: AUTO1
Other Study ID Numbers
- FELIX (AUTO1-AL1)
- 2019-001937-16
- 2019
Start Date (Actual)
2020-06-03
Primary Completion Date (Estimated)
2029-06-30
Study Completion Date (Estimated)
2029-06-30
Enrollment (Actual)
153
Study Type
Interventional
Phase
Phase 1, Phase 2
| Lead Sponsor: | Autolus Limited |
| Information Provided By: | Autolus Limited |
| Last Update Posted: | 2026-04-08 |
Study Overview
Brief Summary
This is a Phase 1b/2 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 (r/r) B cell acute lymphoblastic leukemia (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
Conditions
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Intervention / Treatment
- Biological: AUTO1
Other Study ID Numbers
- FELIX (AUTO1-AL1)
- 2019-001937-16
- 2019
Start Date (Actual)
2020-06-03
Primary Completion Date (Estimated)
2029-06-30
Study Completion Date (Estimated)
2029-06-30
Enrollment (Actual)
153
Study Type
Interventional
Phase
Phase 1, Phase 2