Clinical study with autologous CIK cells for patients with advanced and uresectable sarcoma

Phase 1

• Conditions: patients with advanced and non-resectable sarcoma; MedDRA version: 20.0Level: PTClassification code 10039491Term: SarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002257-11-IT
• Lead Sponsor: AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients with histologically documented unresectable sarcomas which progressed after the first or further line treatments for relapse disease
Age >/= 10 years and Karnofsky or Lansky >/= 70% (patients who present a Karnofsky or Lansky >/= 50% are eligible if it depends solely on orthopedic problems) or ECOG Estimated life expectancy > 3 months;
Signed informed consent
There are also specific additional criteria for the two phases of the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with neuro-psychiatric disorders or social or geographic problems that would prohibit the understanding or rendering informed consent and compliance with the requirements of this protocol are excluded.
There are also specific additional criteria for the two phases of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the maximum tolerated dose (MTD) of CIK;Secondary Objective: -Recommended Phase 2 dose (RP2D)<br>-To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of autologous CIK cells<br>-To explore preliminary evidence of anti-tumour activity of CIK cells <br>-To identify potential (predictive/prognostic) relationships between several bio-markers in the tumor tissue and the observed results; <br>-To evaluate the quality of life of enrolled patients.;Primary end point(s): Incidence of Dose Limiting Toxicities (DLTs);Timepoint(s) of evaluation of this end point: during the first two cycles of treatment (6 weeks fos dose levels -1, 1 and 2; 4 weeks for dose levels 3 and 4)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): pharmacokinetics and pharmacodynamics; PFS; MIC A/B and NKGD2 evaluation;Timepoint(s) of evaluation of this end point: 24 months; 36 months; 24 months