Actively Recruiting
D2C7-IT + 2141-V11 Combination Post-resection in rGBM
Led by Darell Bigner · Updated on 2025-10-23
46
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
Sponsors
D
Darell Bigner
Lead Sponsor
R
Rockefeller University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
D2C7-IT + 2141-V11 Combination Post-resection in rGBM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of study entry
- Histopathologically confirmed WHO grade 4 IDH wildtype glioblastoma or high-grade glioma with molecular features of glioblastoma
- Karnofsky Performance Score of 70% or higher
- Hemoglobin level of at least 9 g/dl before biopsy
- Platelet count of at least 100,000/µl without support; at least 125,000/µl required for biopsy and catheter insertion (can be achieved with transfusion)
- Neutrophil count of at least 1000 before biopsy
- Creatinine level less than or equal to 1.5 times the normal range before biopsy
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN) before biopsy, or up to 3.0 times ULN if Gilbert's Syndrome is diagnosed
- AST and ALT levels less than or equal to 2.5 times ULN
- Prothrombin and partial thromboplastin times less than or equal to 1.2 times normal before biopsy
- Patients with prior thrombosis/embolism may be on anticoagulation with specific management
- Underwent tumor resection 3 to 5 weeks before D2C7-IT treatment, with confirmed recurrent tumor
- Able to undergo brain MRI with and without contrast
- Post-surgery MRI shows residual non-enhancing disease suitable for infusion (no larger than 3 x 3 cm residual enhancing disease)
- Patient or partner is either non-childbearing or agrees to use approved birth control methods
- Signed informed consent form approved by IRB and able to understand the study
You will not qualify if you...
- Females who are pregnant or breastfeeding
- Patients with life-threatening cerebral herniation syndrome
- Severe active co-morbidities including active infections needing IV treatment, immunosuppressive diseases or HIV, severe heart disease (NYHA Class 3 or 4), severe lung disease (FEV1 < 50%), uncontrolled diabetes, or albumin allergy
- Received chemotherapy or bevacizumab within 4 weeks before the study drug (exceptions apply), unless side effects have resolved
- Received immunotherapy within 4 weeks before study drug, unless side effects have resolved
- Treatment with tumor treating fields within 1 week before study drug
- Less than 12 weeks from radiation therapy unless specific progression criteria met
- Incomplete standard of care treatments including surgery and radiation
- Brainstem, cerebellum, or spinal cord lesions; active growing multifocal disease; extensive subependymal disease; tumor crossing midline or leptomeningeal disease
- Use of more than 4 mg per day dexamethasone within 2 weeks before infusion
- Worsening steroid myopathy
- Prior unrelated malignancy requiring active treatment, except certain skin and cervical cancers
- Active autoimmune disease needing systemic immunomodulatory treatment within past 3 months
- Unable to have MRI due to obesity or metal implants such as pacemakers or aneurysm clips
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
A
Annick Desjardins, MD
CONTACT
S
Stevie Threatt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here