D2C7-IT + 2141-V11 Combination Post-resection in rGBM
ConditionRecurrent Glioblastoma IDH Wildtype
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDarell Bigner
About this trial
The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.
Eligibility criteria
Qualifiers
Age ≥ 18 years old at the time of entry into the study
Histopathologically confirmed WHO grade 4 IDHwt GBM (high grade glioma with molecular features of glioblastoma will be eligible)
Karnofsky Performance Score (KPS) ≥ 70%
Hemoglobin ≥ 9 g/dl prior to biopsy
Disqualifiers
Females who are pregnant (negative pregnancy test at screening visit) or breast- feeding
Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate
Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5°F/37.5°C)
Patients with known immunosuppressive disease or known human immunodeficiency virus infection
Trial design
Treatments tested in this trial
- D2C7-IT
- 2141 V11
Treatment groups
46 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov