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OncoMatch/Clinical Trials/NCT06193759

Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)

Is NCT06193759 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) and Group A Standard-of-Care Backbone Therapy for medulloblastoma, childhood.

Phase 1RecruitingChildren's National Research InstituteNCT06193759Data as of May 2026

Treatment: Multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) · Group A Standard-of-Care Backbone TherapyThis 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 tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Prior therapy

Cannot have received: immunotherapy with an investigational agent

Prior immunotherapy with an investigational agent within the 28 days prior to planned date of procurement collection for TSA-T manufacturing.

Cannot have received: ATG, Campath or other immunosuppressive T cell monoclonal antibodies (ATG, Campath)

Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.

Lab requirements

Blood counts

ANC 750/1L; ALC >500/1L; Platelets 75K

Kidney function

Serum creatinine 1.0 mg/dL or 1.5x ULN for age (whichever is higher)

Liver function

Bilirubin 3x ULN; AST and ALT <5x ULN

Adequate organ function, defined below: i. ANC 750/1L. ii. Absolute lymphocyte count (ALC) >500/1L. iii. Platelets 75K. iv. Bilirubin 3xULN. v. AST and ALT <5x ULN. vi. Serum creatinine 1.0 mg/dL or 1.5x ULN for age (whichever is higher). vii. Pulse oximetry >90% on room air.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's National Hospital · Washington D.C., District of Columbia

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