Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas

Conditions

• Currently Only Enrolling Glioblastoma Patients at First Recurrence

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Neural Stem Cells-expressing CRAd-S-pk7 — BIOLOGICAL
  Given intracerebrally
• Resection — PROCEDURE
  Undergo surgical resection

Study Details

This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.

Key Dates

First listed

Dec 1, 2021

Start date

May 2, 2023

Status verified

Sep 2026

Primary completion

Aug 4, 2027

Completion

Aug 4, 2027

Study Design

Enrollment

36 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (NSC-CRAd-S-pk7)
  Patients undergo standard surgical resection, and during surgery the first dose of study agent is injected into the wall of the resection cavity. Patients then receive three additional doses every week or every two weeks (depending on when they enroll in the study) via a catheter that was placed during surgery

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days post removal of Rickhams ]

Locations (4)

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