Trials / Completed
CompletedNCT03389035
Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Pediatric and Adult Patients With r/r ALL Post HSCT
Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Academic / Other
- Sex
- All
- Age
- 1 Year – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CARCIK-CD19 | Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene |
Timeline
- Start date
- 2017-12-20
- Primary completion
- 2021-03-31
- Completion
- 2022-12-30
- First posted
- 2018-01-03
- Last updated
- 2023-05-06
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03389035. Inclusion in this directory is not an endorsement.