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

Phase 1

Completed

• Conditions: Sarcoma
• Interventions: Drug: Autologous CIK

• Registration Number: NCT04802070
• Lead Sponsor: Prof. Franca Fagioli

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Study First Submitted: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIK	Autologous CIK	-

Primary Outcome Measures

Name	Time	Method
DLT	6 weeks	Incidence of dose-limiting toxicity (DLT) associated with CIK autologous cells administration

Trial Locations

Locations (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita; 🇮🇹 Turin, Italy