Trials / Unknown
UnknownNCT05429905
Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells (CART2219.1) for Relapsed Refractory B-Lineage Leukaemia
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- KK Women's and Children's Hospital · Other Government
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to deliver dual-targeting CAR-T cell therapy (CART 2219.1) as a salvage treatment to patients with relapsed/refractory B-lineage leukaemia in place of stem cell transplant or irradiation.
Conditions
- Lymphoblastic Leukemia
- Lymphoblastic Leukemia, Acute, Childhood
- Lymphoblastic Leukemia in Children
- Lymphoblastic Leukemia, Acute Adult
- CAR
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Phase I | * Dose level 0: CAR+CD3+ 0.4 x 10e6/kg (de-escalation dose) * Dose level 1: CAR+CD3+ 1 x 10e6/kg (starting dose) * Dose level 2: CAR+CD3+ 2.5 x 10e6/kg. Dose-escalations for adults and paediatrics will be performed in 2 independent strata for determination of RP2D. |
| BIOLOGICAL | Phase II | RP2D will be determined in Phase I |
Timeline
- Start date
- 2022-07-18
- Primary completion
- 2024-12-01
- Completion
- 2025-12-01
- First posted
- 2022-06-23
- Last updated
- 2023-03-09
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05429905. Inclusion in this directory is not an endorsement.