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

A phase I study of adoptive immunotherapy with Cytokine-Induced Killer (CIK) cells in relapsed and non-resectable sarcomas after multimodal treatment. - CIK Cells for Advanced Sarcoma Trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002257-11-IT

Enrollment

Registered

2020-10-21

Start date

2020-12-14

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with advanced and non-resectable sarcoma MedDRA version: 20.0 Level: PT Classification code 10039491 Term: Sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Cellule Autologhe Cytokine Induced Killer Product Code: [CIK] Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: CIK Concentration unit: IU/kg international

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically documented unresectable sarcomas which progressed after the first or further line treatments for relapse disease Age >/= 10 years and /= 70% (patients who present a Karnofsky or Lansky >/= 50% are eligible if it depends solely on orthopedic problems) or ECOG 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the maximum tolerated dose (MTD) of CIK;Secondary Objective: -Recommended Phase 2 dose (RP2D) -To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of autologous CIK cells -To explore preliminary evidence of anti-tumour activity of CIK cells -To identify potential (predictive/prognostic) relationships between several bio-markers in the tumor tissue and the observed results; -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)	—

Measure

Time frame

Main Objective: To determine the maximum tolerated dose (MTD) of CIK;Secondary Objective: -Recommended Phase 2 dose (RP2D) -To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of autologous CIK cells -To explore preliminary evidence of anti-tumour activity of CIK cells -To identify potential (predictive/prognostic) relationships between several bio-markers in the tumor tissue and the observed results; -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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactPI della sperimentazione - Servizio

Prof.ssa Franca Fagioli

franca.fagioli@unito.it+390113135447

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026