NCT04922723

Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma

A Study of Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE).

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

TMZ is a standard therapy for GBM. The study will demonstrate that Daratumumab can collaborate with TMZ to enhance the cytotoxicity against GBM cells. Collectively, the preclinical data along with existing in vivo studies by others provides the rationale for therapeutic targeting of CD38 in GBM and its microenvironment. Daratumumab is commercially available, is safe and well tolerated when combined with alkylating chemotherapy, radiation therapy and has attained therapeutic CSF levels. Thus, the addition of Daratumumab to the frontline treatment regimen of GBM can potentially have a significant clinical benefit. Approximately 16 subjects will be enrolled in this trial. Up to 6 will be enrolled in the phase I part and 10 to 13 in the phase II part to come up with a total of 16 patients with 2 phases combined.

Detailed description

Glioblastoma (GBM) is an aggressive brain cancer. Current therapeutic strategies include maximal safe surgical resection followed by course of Temozolomide (TMZ) and radiation therapy (RT). Despite trimodality treatment, recurrence remains inevitable. Our study will use Daratumumab, an anti-CD38 monoclonal antibody, in combination with TMZ and RT in newly diagnosed GBM patients. There is pre-clinical evidence suggesting Daratumumab is cytotoxic to GBM in a multimodal fashion, its safe when combined with chemotherapy \& radiation therapy as well as has the potential to cross blood brain barrier.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy.

Timeline

• Start date: 2022-10-03
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2021-06-11
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study