Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-24 @ 2:40 PM
NCT ID:
NCT06193759
Eligibility Criteria:
Inclusion Criteria:
RECIPIENT PROCUREMENT (BLOOD COLLECTION FOR TSA-T MANUFACTURING) INCLUSION CRITERIA
* New diagnosis of CNS embryonal tumors: medulloblastoma, embryonal tumor with multilayered rosettes (ETMR), pineoblastoma, atypical teratoid/rhabdoid tumor, and embryonal tumor, not otherwise specified (NOS).
* \<5 years of age at enrollment.
* Lansky score of ≥60% (see appendix B).
* Organ function:
ANC ≥750/µL. Absolute lymphocyte count (ALC) \>500/μL. Platelets ≥75K. Bilirubin ≤3xULN. Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \<5x upper limit of normal (ULN). Serum creatinine ≤1.0mg/dL or 1.5x ULN for age (whichever is higher). Pulse oximetry \>90% on room air.
* Parent(s)/guardian(s) capable of providing informed consent.
* Availability of sufficient pre-trial fresh frozen tumor tissue (approximately 50 mg).
* Patient deemed to be of sufficient size to undergo PBMC pheresis for TSA-T generation and PBSC rescue.
* Patient is a surgical candidate for placement of Rickham reservoir in the opinion of a physician.
RECIPIENT INCLUSION CRITERIA FOR INITIAL TSA-T ADMINISTRATION AND FOR ADDITIONAL INFUSIONS
* Lansky score of ≥60%.
* Organ function:
Bilirubin ≤3x ULN. AST/ALT ≤5x ULN. Serum creatinine ≤1.0mg/dL or 1.5x ULN for age (whichever is higher). Pulse oximetry \>90% on room air.
\- Neurologic status: Patient must have a stable neurologic exam for 2 weeks, on a stable or decreasing dose of steroids, prior to administration of the first dose of TSA-T cells, and stability for 1 week prior to all subsequent infusions. The exams demonstrating stability must be performed by the study team, although these may occur via telemedicine if necessary. Patient must agree to a brief (\<72 hours) course of steroids
Exclusion Criteria:
PROCUREMENT EXCLUSION CRITERIA
* Patients with uncontrolled infections.
* Patients with known HIV infection.
* Prior immunotherapy with an investigational agent within the last 28 days prior to procurement.
* Patients with medulloblastoma of the SHH subtype.
* Patients who have overly bulky tumors on imaging are ineligible. These include the following:
Tumor with any evidence of herniation or significant midline shift. Tumor with a significant brainstem component. Patients who are deemed to have overly bulky tumor by the principal investigator (PI) of the study.
RECIPIENT EXCLUSION CRITERIA FOR INITIAL AND SUBSEQUENT TSA-T INFUSIONS
* Patients with uncontrolled infections.
* Patients who have overly bulky tumors on imaging are ineligible. These include the following:
Tumor with any evidence of herniation or significant midline shift. Tumor with a significant brainstem component. Patients who are deemed to have overly bulky tumor by the PI of the study.
* Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.
* Patients receiving dexamethasone at a dose of \>0.05mg/kg. All patients who qualify based on the above inclusion and exclusion criteria will be eligible for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
4 Years
Study:
NCT06193759
Study Brief:
Protocol Section:
NCT06193759