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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05835687
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • B7-H3-CAR T cells — DRUG
    Autologous T cells transduced with a lentiviral vector expressing a B7-H3-CAR with a CD28z signaling domain and 41BB ligand (B7-H3-CAR T cells). Four (4) infusions of B7-H3-CAR T cells will be locoregionally administered via CNS reservoir catheter.

Study Details

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).

Key Dates

Start date
Apr 27, 2023
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (relapsed/refractory CNS tumors)
    Patients with B7-H3-positive relapsed/refractory non-brainstem primary CNS tumors.
  • Experimental: Arm B (diffuse midline gliomas [DMG])
    Patients with DMG.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Four (4) weeks after the first B7-H3-CAR T-cell infusion or 7 days after the fourth B7-H3-CAR T cell infusion, whichever is longer ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Tabatha E. Doyle, RN
[email protected]
901-595-2544

Find similar trials in Memphis, TN

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
St. Jude Children's Research Hospital· Memphis, TN

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