Trials / Recruiting
RecruitingNCT05038696
ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Chimeric-Antigen Receptor (CAR) T-Cell Therapy Using Multiple CARs and Cell Marker Profiling in High Risk and Relapsed/ Refractory B-Lineage Acute Lymphoblastic Leukaemia
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- National University Hospital, Singapore · Academic / Other
- Sex
- All
- Age
- 6 Months – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).
Detailed description
Patients will receive CART-cells with one or more specificities according to the phenotypic profile of the leukemic cells in each individual patient. This will allow targeting the entire leukemia cell population to induce deeper and more durable remissions. Although it would be possible to administer CART-cells targeting all possible antigens to all patients, this indiscriminate approach would increase the CAR T-cell dose and hence, the risk of toxicity in patients that could be effectively treated with a lower, less toxic, CAR T-cell dose. Moreover, the cost of the procedure increases proportionally with the number of CAR T-cells used, limiting our capacity to enrol other patients. Reducing the number of CART-cells below the dose that we set, will inevitably increase the risk of treatment failure, according to the literature and our own experience.
Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Lymphoblastic Leukemia
- Lymphoblastic Leukemia, Acute Adult
- Lymphoblastic Leukemia in Children
- CAR
- CAR T-Cell-Related Encephalopathy Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CAR T-cell therapy | This is a single-centre, phase I study to determine the efficacy and safety of CAR T-cell therapy in patients with high-risk B-ALL, refractory or relapsed B-ALL. |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2026-05-01
- Completion
- 2026-08-01
- First posted
- 2021-09-09
- Last updated
- 2021-09-09
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05038696. Inclusion in this directory is not an endorsement.