CUE-102 in Recurrent Glioblastoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
David Reardon, MD
Study ID
NCT06917885
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CUE-102 — BIOLOGICAL
    A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.

Study Details

The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM). The name of the study drug involved in this study is: -CUE-102 (a type of fusion protein)

Key Dates

Start date
Jul 30, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CUE-102
    The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete: * Baseline visit * Imaging every 9 weeks starting at Cycle 3 * Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles) --Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily. * End of Treatment visit with imaging * Long-Term Follow Up: every 3-4 months

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting-toxicities (DLT) [ Time Frame: 3 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
David A Reardon, MD
[email protected]
617-632-4750
David A Reardon, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02115
David A Reardon, MD
[email protected]
647-632-4750
David A Reardon, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Brigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MA

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