ALLOGENEIC PERIPHERAL BLOOD-DERIVED CD56+ NATURAL KILLER CELLS, CO-CULTURED WITH K562-MB15-41BBI CELL LINE for Sarcoma

Inclusion criteria

• {"criterion_text":"- Patients aged 0-40 years diagnosed with malignant sarcoma, who at the end of conventional treatment still have detectable residual disease (based on imaging techniques) or in case of stable disease or minimal disease when there is an absence of clinical benefit from chemotherapy (poor tolerance due to adverse effects related to chemotherapy)."}
• {"criterion_text":"- Lansky/Karnofsky index > 60%."}
• {"criterion_text":"- Mild-moderate (<4) organ functional impairment (hepatic, renal, respiratory), according to National Cancer Institute criteria (NCI CTCAE v5.0)."}
• {"criterion_text":"- Left ventricular ejection fraction >39%."}
• {"criterion_text":"- Adult subjects who had voluntarily signed the informed consent prior to the first intervention of the study."}
• {"criterion_text":"- Minor subjects whose representative/legal guardian voluntarily signed the informed consent prior to the first intervention of the study."}
• {"criterion_text":"- In the case of mature minors (12 - 17 years of age), in addition to the consent signed by the legal guardian, the minor's assent will be obtained."}
• {"criterion_text":"- Women of childbearing capacity must have a negative pregnancy test at inclusion and must agree to use highly effective contraceptive methods (diaphragms plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or vasectomized partner) during their participation in the study and within 30 days of the last visit."}
• {"criterion_text":"- Presence of a compatible haploidentical donor (parent or sibling)."}

Exclusion criteria

• {"criterion_text":"- Patients with a history of poor therapeutic compliance."}
• {"criterion_text":"- Patients who after a psycho-social evaluation are censored as unsuitable for the procedure.  Socio-familial situation that makes proper participation in the study impossible.  Patients with emotional or psychological problems secondary to the disease, such as post-traumatic stress disorder, phobias, delirium, psychosis, requiring specialist support.  Evaluation of the involvement of family members in the patient's health.  Impossibility to understand information about the trial."}
• {"criterion_text":"- Severe functional organ impairment (hepatic, renal, respiratory) (4), according to the criteria of the National Cancer Institute (NCI CTCAE 5.0)."}
• {"criterion_text":"- The contraindications, interactions, precautions for use and dose reductions indicated in the corresponding data sheets should be considered."}
• {"criterion_text":"- Subjects who have been administered other investigational drugs in the 90 days prior to inclusion."}

Primary endpoints

• {"endpoint_text":"- Toxicity will be classified according to the common toxicity criteria established by the National Cancer Institute (CTC NCI, version 5.0).","definition_or_measurement_approach":"Classified according to the National Cancer Institute Common Toxicity Criteria (CTC NCI, version 5.0)."}

Secondary endpoints

• {"endpoint_text":"- Incidence of episodes of febrile neutropenia, bacteraemia, infections (viral, fungal), haematological recovery and hospital admission associated with treatment.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Five-year disease progression rate after treatment with NK cells + IL-2. This will be determined by imaging techniques.","definition_or_measurement_approach":"Determined by imaging techniques."}
• {"endpoint_text":"- Expression levels of NK cell inhibitory/activating ligands in solid tumour samples and patient serum. These shall be determined by immunohistochemistry and PCR techniques.","definition_or_measurement_approach":"Determined by immunohistochemistry and PCR techniques."}

Spain

Earliest CTIS Part Ii Submission Date

05-04-2024

Latest Decision Or Authorization Date

18-04-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Hospital Universitario La Paz

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain