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Study of Adoptive Immunotherapy in Relapsed and Non-resectable Sarcomas After Multimodal Treatment. — CAST  

Sarcoma Clinical Trial

Official title:
A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.

Clinical Trial 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)

Clinical Trial Description

In the first part of the study the patient's' peripheral blood collected from and CIK cell expansion and storage at the Regina Margherita Children's Hospital Cell Factory. Approximately 40 patients will be enrolled in part 1 (range: 30 - 50 patients). The second part of the study will be a 3+3 dose escalation design to determine the MTD/RP2D. A Safety Monitoring Committee (SMC) will be appointed to make dose escalation decisions. Approximately 30 patients will be enrolled in this part (range: 6 - 36 patients). Only one infusion of autologous CIK cells will be carried out at each cycle, every 21 days at the 1st, 2nd and 3rd dose levels and every 15 days at the 4th, 5th 6th dose levels. A maximum of 6 cycles will be performed (patient with complete disease remission patients who benefit from treatment might also receive more cycles at the Investigator's discretion) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03782363
Study type Interventional
Source Italian Sarcoma Group
Contact
Status Withdrawn
Phase Phase 1
Start date December 18, 2020
Completion date April 1, 2023
View Details
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