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

Description

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 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.

Conditions

Medulloblastoma, Childhood, Atypical Teratoid/Rhabdoid Tumor of CNS, Embryonal Tumor With Multilayered Rosettes, Pineoblastoma, Embryonal Tumor of CNS

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Study Overview

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Study Details

Study overview

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 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.

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

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

Condition
Medulloblastoma, Childhood
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Hospital, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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.
  • * Lansky score of ≥60%.
  • * Organ function:
  • * 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:
  • * Patients with uncontrolled infections.
  • * Patients who have overly bulky tumors on imaging are ineligible. These include the following:
  • * 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.

Ages Eligible for Study

1 Day to 4 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's National Research Institute,

Eugene Hwang, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Brian Rood, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

2032-12-29