Trials / Recruiting
RecruitingNCT05648019
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- KK Women's and Children's Hospital · Other Government
- Sex
- All
- Age
- 0 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
Detailed description
This is a single arm, open-label, multi-center, phase II feasibility study to deliver point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed / refractory B-lineage leukaemia / lymphoma. The study consists of the following phases: 1. Screening phase: Eligibility; enrolment 2. Preparatory phase: Bridging therapy (if required); leukapheresis; CAR T manufacturing; lymphodepletion. 3. Treatment phase: Infusion of single dose of anti-CD19 CAR T-cells 4. Follow-up Phase: Efficacy and safety monitoring up to 24 months
Conditions
- Lymphoblastic Leukemia
- Lymphoblastic Leukemia in Children
- Lymphoblastic Leukemia, Acute Adult
- B-cell Acute Lymphoblastic Leukemia
- Large B-cell Lymphoma
- CAR
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Anti-CD19 CAR T-cells | A target per-protocol dose of vi able CD19 CAR transduced T-cells will consist of a single infusion of 0.2 to 5.0 x 10e6 lentiviral-transduced viable 41BB-CD19 CAR T-cells per kg body weight. |
Timeline
- Start date
- 2022-03-15
- Primary completion
- 2025-12-01
- Completion
- 2026-12-01
- First posted
- 2022-12-13
- Last updated
- 2023-03-09
Locations
2 sites across 1 country: Singapore
Source: ClinicalTrials.gov record NCT05648019. Inclusion in this directory is not an endorsement.