RECRUITING

Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors

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Conditions

Central Nervous System NeoplasmsAtypical Teratoid/Rhabdoid TumorDiffuse Midline Glioma, H3 K27M-MutantEpendymomaHigh Grade GliomaGlioblastomaMedulloblastoma

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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

Loc3CAR is a Phase I clinical trial evaluating the use of autologous B7-H3-CAR T cells for participants ≤ 21 years old with primary CNS neoplasms. B7-H3-CAR T cells will be locoregionally administered via a CNS reservoir catheter. Study participants will be divided into two cohorts: cohort A with B7-H3-positive relapsed/refractory non-brainstem primary CNS tumors, and cohort B with diffuse midline gliomas (DMG). Participants will receive four (4) B7-H3-CAR T cell infusions over a 4 week period. The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give patients with primary brain tumors. Primary objectives * To determine the safety, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the locoregional delivery of autologous B7-H3-CAR T cells in patients ≤ 21 years of age with recurrent/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). Secondary objectives * To assess the efficacy, defined as sustained objective response, a partial response (PR) or complete response (CR) observed anytime on active treatment with B7-H3-CAR T cells in patients with relapsed/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). * To characterize and monitor neurologic toxicities in patients while on study (Cohort A and B).

Official Title

Loc3CAR: Locoregional Delivery of B7-H3-specific Chimeric Antigen Receptor Autologous T Cells for Pediatric Patients With Primary CNS Tumors

Quick Facts

Study Start:2023-04-27
Study Completion:2028-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05835687

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:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≤ 21 years of age
  2. 2. Primary CNS tumor
  3. 3. For Cohort A, must have evidence of relapsed or refractory non-brainstem CNS tumor
  4. 4. For Cohort B, must meet one of the following criteria:
  5. * Adequate tumor tissue from primary tumor resection or biopsy for central pathology review (i.e., B7-H3 expression evaluation by immunohistochemistry \[IHC\] or H3K27M mutation if pontine lesion)
  6. * Has a diagnosis of diffuse midline glioma that harbors a mutation associated with this entity (e.g. H3K27M)
  7. * Has presumptive/suspected brainstem high-grade neoplasm with available imaging for central imaging review
  8. 5. Life expectancy of \> 12 weeks
  9. 6. Adult patient, parent or legal guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
  1. 1. Participant has other clinically significant medical disorders (e.g. serious infections or significant cardiac, pulmonary, hepatic, psychiatric, or other organ dysfunction) that could compromise their ability to tolerate protocol therapy or would interfere with study procedure.

Contacts and Locations

Study Contact

Tabatha E. Doyle, RN
CONTACT
901-595-2544
tabatha.doyle@stjude.org
Jean Laboe, MSN, RN
CONTACT
901-595-1693
jean.laboe@stjude.org

Principal Investigator

Christopher DeRenzo, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Kelsey Bertrand, MD, MSc
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Giedre Krenciute, PhD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Christopher DeRenzo, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
  • Kelsey Bertrand, MD, MSc, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital
  • Giedre Krenciute, PhD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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 Date2023-04-27
Study Completion Date2028-03

Study Record Updates

Study Start Date2023-04-27
Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

  • Central Nervous System Neoplasms
  • Atypical Teratoid/Rhabdoid Tumor
  • Diffuse Midline Glioma, H3 K27M-Mutant
  • Ependymoma
  • High Grade Glioma
  • Glioblastoma
  • Medulloblastoma