Trials / Recruiting
RecruitingNCT05043571
CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia
Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- National University Hospital, Singapore · Academic / Other
- Sex
- All
- Age
- 6 Months – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).
Detailed description
A major obstacle to the development of effective CAR T-cells for T-cell malignancies is that the surface marker profile of malignant T-cells largely overlaps that of activated T lymphocytes. We developed a CAR T-cell approach that targets CD7, a T-cell marker highly expressed in all cases of T-cell ALL, including ETP-ALL. Its expression is also highly stable even in T-ALL cells exposed to chemotherapy. To prevent fratricide effect of the T cells, surface CD7 expression are effectively downregulated with the expression of an anti-CD7 Protein Expression Blocker (PEBL). Patients will receive anti-CD7 PEBL CART-cells. This will allow targeting the entire leukemia cell population to induce deeper and more durable remissions.
Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Lymphoblastic Leukemia
- Lymphoblastic Leukemia, Acute Adult
- Lymphoblastic Leukemia in Children
- CAR
- CAR T-Cell-Related Encephalopathy Syndrome
- Refractory Leukemia
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 T-ALL, refractory or relapsed T-ALL. |
Timeline
- Start date
- 2021-09-08
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2021-09-14
- Last updated
- 2021-09-14
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05043571. Inclusion in this directory is not an endorsement.