Trials / Completed
CompletedNCT03289455
CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)
A Single-Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity Of AUTO3, a CAR T Cell Treatment Targeting CD19 And CD22 in Paediatric And Young Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Autolus Limited · Industry
- Sex
- All
- Age
- 1 Year – 24 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.
Detailed description
The study will consist of 2 phases, a Phase I or dose escalation phase and a Phase II or expansion phase. Paediatric or young adult patients with relapsed or refractory B cell ALL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3 which is a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO3 intravenously as a single or split dose and will then enter a 24-month follow-up period.
Conditions
- B Acute Lymphoblastic Leukemia
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Refractory Childhood Acute Lymphoblastic Leukemia
- B-cell Acute Lymphoblastic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AUTO3 (CD19/22 CAR T cells | Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose. |
Timeline
- Start date
- 2017-06-26
- Primary completion
- 2020-05-18
- Completion
- 2020-05-18
- First posted
- 2017-09-21
- Last updated
- 2021-02-01
- Results posted
- 2021-02-01
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03289455. Inclusion in this directory is not an endorsement.