Trials / Completed
CompletedNCT04802070
Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Prof. Franca Fagioli · Academic / Other
- Sex
- All
- Age
- 10 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
Monocentric, phase I study for advanced sarcoma with adoptive immunotherapy with Cytokine-Induced Killer (CIK). In the first part of the study Patient's' peripheral blood will be collected and CIK cell expansion and storage will occur at the Regina Margherita Children's Hospital Cell Factory. In the second part of the study the Maximum Tolerated Dose (MTD) will be determined in order to find the Recommended Dose for Phase II (RP2D)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Autologous CIK | Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory (4 dose levels) |
Timeline
- Start date
- 2021-01-11
- Primary completion
- 2023-03-16
- Completion
- 2023-03-16
- First posted
- 2021-03-17
- Last updated
- 2023-04-12
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04802070. Inclusion in this directory is not an endorsement.