NCT06177964

Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)

Recruiting now Phase 2 Last updated 13 August 2025

What this trial tests

Phase 2 trial testing Lerapolturev in Recurrent Supratentorial Glioblastoma in 92 participants. Currently enrolling.

Timeline

15 July 2024

Primary endpoint
1 February 2029

1 February 2029

Quick facts

Lead sponsor	Darell Bigner
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	92
Start date	15 July 2024
Primary completion	1 February 2029
Estimated completion	1 February 2029
Sites	1 location across United States

Drugs / interventions tested

• Lerapolturev — full drug profile →
• Lomustine Pill — full drug profile →

Conditions studied

• Recurrent Supratentorial Glioblastoma — all drugs for Recurrent Supratentorial Glioblastoma →

Sponsor

Darell Bigner — full company profile →

Who can join

18 and older, any sex, with Recurrent Supratentorial Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of patients at each dose level who experienced a dose-limiting toxicity - Stage 1
  Time frame: Up to 1 year
  Dose-limiting toxicities (DLTs) are defined as any of the following events that are possibly, probably, or definitely attributable to study treatment (i.e., lerapolturev) during dose escalation (Stage 1): * Any Grade 3 or any Grade 4 toxicity within 2 weeks, including cerebral edema or worsening neurologic symptoms * Any life-threatening event within 2 weeks * Treatment-related death at least pos
• Proportion of patients who experience an unacceptable toxicity - Stage 2
  Time frame: Up to 1 year
  Unacceptable toxicity is defined as any of the following events that are possibly, probably, or definitely attributable to study treatment: * Any Grade 3 or any Grade 4 toxicity within 2 weeks, including cerebral edema or worsening neurologic symptoms * Any life-threatening event within 2 weeks * Treatment-related death at least possibly, probably, or definitely attributable to study treatment *
• Overall survival (OS) - Stage 2
  Time frame: 2 years
  Median OS, where OS is defined as the time between randomization and death

Sponsor's own description

The purpose of this research study is to determine the safety and efficacy of administering two doses of lerapolturev in residual disease (within tumor margins) after surgery, followed later by repeated injections of lerapolturev in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adult patients diagnosed with recurrent glioblastoma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Device-assisted strategies for drug delivery across the blood-brain barrier to treat glioblastoma.
   Mokarram N, Case A, Hossainy NN, Lyon JG, et al · · 2025 · cited 17× · PMID 39790893 · DOI 10.1038/s43246-024-00721-y
2. Overcoming the Blood-Brain Barrier for Drug Delivery to the Brain.
   Katz JS, Slika H, Sattari SA, Malla AP, et al · · 2025 · cited 4× · PMID 40787406 · DOI 10.1021/acsomega.5c00364
3. Polio virotherapy provokes MDA5 signaling and CD4<sup>+</sup> T cell help to mediate cancer <i>in situ</i> vaccination.
   Gromeier M, Brown MC. · · 2025 · cited 1× · PMID 40626649 · DOI 10.1128/mmbr.00040-24
4. Recurrent Glioblastoma and the Tumor Immune Landscape: Emerging Immunotherapeutic Strategies.
   Cao Z, Tong S, Wang Z, Ji C, et al · · 2026 · PMID 41809120 · DOI 10.2147/itt.s581012
5. Lymphotropic Virotherapy Induces DC and High Endothelial Venule Inflammation, Promoting the Antitumor Efficacy of Intratumor Virus Administration.
   Ludwig AL, McKay ZP, Carter GP, Katz MA, et al · · 2026 · PMID 41270238 · DOI 10.1158/2326-6066.cir-25-0756
6. Lymphotropic Virotherapy Engages DC and High Endothelial Venule Inflammation to Mediate Cancer<i>In Situ</i>Vaccination
   Ludwig AL, McKay ZP, Carter GP, Katz MA, et al · · 2025 · DOI 10.1101/2025.04.23.25326279