Status:
RECRUITING
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Lead Sponsor:
Children's National Research Institute
Conditions:
Medulloblastoma, Childhood
Atypical Teratoid/Rhabdoid Tumor of CNS
Eligibility:
All Genders
1-4 years
Phase:
PHASE1
Brief Summary
This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumo...
Detailed Description
This study will be conducted at Children's National Hospital (CNH) in Washington, DC. TSA-T products will be manufactured at the cell therapy Good Manufacturing Practice (GMP) facility at CNH. Patient...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 29 2032
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06193759
Start Date
September 20 2024
End Date
December 29 2032
Last Update
September 26 2024
Active Locations (1)
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1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010