ALLOGENIC BONE MARROW-DERIVED MESENCHYMAL STEM CELLS TRANSDUCED WITH ICOVIR-5, EX VIVO EXPANDED for Relapsed or refractory extracranial solid tumors

Inclusion criteria

• {"criterion_text":"- Patients aged between 1 year and ≤21 years."}
• {"criterion_text":"- Informed consent in writing according to current legislation."}
• {"criterion_text":"- Washing periods compared to previous treatments."}
• {"criterion_text":"- Patients with extra-cranial solid tumor, relapsed or refractory, for which there is no standard curative treatment"}
• {"criterion_text":"- Disease measurable or evaluable according to RECIST criteria v1.1."}
• {"criterion_text":"- Patients for whom the combination with the proposed chemotherapy and radiotherapy regimens is considered adequate. Patients may have previously received the same schemes."}
• {"criterion_text":"- Adequate functional status, organic function (renal, hepatic) and hematological values."}
• {"criterion_text":"- Patient capable of complying with the treatment and plan of visits and evaluations."}
• {"criterion_text":"- Life expectancy ≥3 months."}
• {"criterion_text":"- Appropriate contraceptive methods for sexually active men and women of childbearing age."}
• {"criterion_text":"- Negative pregnancy test for women of childbearing age."}

Exclusion criteria

• {"criterion_text":"- Previous treatment with Celyvir."}
• {"criterion_text":"- Active acute toxicities of previous treatment grade ≥3 of the CTCAE v4."}
• {"criterion_text":"- Known and uncontrolled bacterial, viral, fungal or parastaria active infection."}
• {"criterion_text":"- Known active infection for hepatitis or HIV virus."}
• {"criterion_text":"- Patients with CNS metastases should be clinically stable and with stable or decreasing doses of steroids for at least one week."}
• {"criterion_text":"- Serious active and past systemic diseases that are clinically significant or uncontrolled, which may imply an added risk for the patient."}
• {"criterion_text":"- Allergy to Penicillin or its derivatives."}

Primary endpoints

• {"endpoint_text":"- Dose confirmation phase: Rate of dose-limiting toxicities.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Expansion phase: Rate of objective responses (complete and partial responses) of the combination.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Feasibility of the combination: rate of patients who meet selection criteria who can receive at least one cycle of the combination of Alo-Celyvir with chemo-radiotherapy and measurement of the time from recruitment to the preparation and administration of Alo-Celyvir.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Dose confirmation phase: Rate of objective responses (complete and partial responses) of the combination.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression free survival.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Global survival.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Rate of adverse events.","definition_or_measurement_approach":""}

Spain

Earliest CTIS Part Ii Submission Date

25-09-2024

Latest Decision Or Authorization Date

10-10-2024

Processing Time Days

15

Number Of Sites

2

Number Of Participants

24

Primary sponsor

Full Name

Fundacion Para La Investigacion Biomedica Hospital Infantil Universitario Nino Jesus

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain