Phase I, open label, prospective, single-center, non-randomized, dose escalation clinical trial aiming to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of systemic transduced donor-derived NKG2D-CAR memory T cell infusions (Arm A), and of dual treatment, with both systemic and locally transduced donor-derived NKG2D-CAR memory T cell infusions (Arm B).
Age: ≤ 40 years at the time of recurrence or progression with any type of sarcoma that has recurred or not responded to standard therapy and is deemed incurable by standard therapy.
If the patient doesn´t have adequate accessible tumor for biopsy (at least 1 cm diameter).
Procedures employed to acquire biopsies for tumor lysates will be limited to percutaneous needle or core biopsies, thoracoscopic excision or open biopsies of readily accessible lesions. Pulmonary lesions may be biopsied but extensive surgery such as thoracotomy or laparotomy should not be employed.
Patients who require biopsy should not be enrolled if in the opinion of the principal investigator (PI), the tumor site places the patient at substantial related risk from the biopsy procedure.
Enrolled in another treatment protocol.
Cardiac disorder defined as LVFE < 45% determined by ECHO.
Human Immunodeficiency Virus (HIV) positive test.
Presence of active or prior CMV, EBV, hepatitis B or C as indicated by serology.
Antonio Pérez Martínez
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Sponsor institution