RECRUITING

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

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Conditions

Medulloblastoma, ChildhoodAtypical Teratoid/Rhabdoid Tumor of CNSEmbryonal Tumor With Multilayered RosettesPineoblastomaEmbryonal Tumor of CNS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-09-20
Study Completion:2032-12-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06193759

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.

Ages Eligible for Study:1 Day to 4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * \<5 years of age at enrollment.
  3. * Lansky score of ≥60% (see appendix B).
  4. * Organ function:
  5. * Parent(s)/guardian(s) capable of providing informed consent.
  6. * Availability of sufficient pre-trial fresh frozen tumor tissue (approximately 50 mg).
  7. * Patient deemed to be of sufficient size to undergo PBMC pheresis for TSA-T generation and PBSC rescue.
  8. * Patient is a surgical candidate for placement of Rickham reservoir in the opinion of a physician.
  9. * Lansky score of ≥60%.
  10. * Organ function:
  1. * Patients with uncontrolled infections.
  2. * Patients with known HIV infection.
  3. * Prior immunotherapy with an investigational agent within the last 28 days prior to procurement.
  4. * Patients with medulloblastoma of the SHH subtype.
  5. * Patients who have overly bulky tumors on imaging are ineligible. These include the following:
  6. * Patients with uncontrolled infections.
  7. * Patients who have overly bulky tumors on imaging are ineligible. These include the following:
  8. * Patients who received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of TSA-T infusion.
  9. * 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.

Contacts and Locations

Study Contact

Brian Rood, MD
CONTACT
2024762314
BROOD@childrensnational.org
Fahmida Hoq, MBBS
CONTACT
2024763634
FHOQ@childrensnational.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-20
Study Completion Date2032-12-29

Study Record Updates

Study Start Date2024-09-20
Study Completion Date2032-12-29

Terms related to this study

Additional Relevant MeSH Terms

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