Actively Recruiting
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
Led by Darell Bigner · Updated on 2025-05-06
90
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
D
Darell Bigner
Lead Sponsor
R
Rockefeller University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 1 study of an anti-CD40 monoclonal antibody (2141-V11) in combination with D2C7-IT for patients with recurrent World Health Organization (WHO) grade III or IV malignant glioma at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.
CONDITIONS
Official Title
Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histopathologically confirmed recurrent supratentorial WHO grade 3 or 4 malignant glioma
- For TMD subgroup: tumor amenable for Tumor Monorail Device implantation as decided by neurosurgeon
- Patients or partners must be non-childbearing or agree to use approved contraception methods
- Karnofsky Performance Score of 70% or higher
- Hemoglobin level of 9 g/dl or above prior to biopsy
- Platelet count of at least 100,000/µl unsupported; 125,000/µl required for biopsy and catheter insertion
- Neutrophil count of 1000 or higher prior to biopsy
- Creatinine level less than or equal to 1.5 times normal prior to biopsy
- Total bilirubin less than or equal to 1.5 times upper limit of normal (ULN), with exceptions for Gilbert's Syndrome
- AST/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 prior to biopsy
- Recurrent tumor confirmed by histopathology at biopsy
- Ability to read, understand, and sign informed consent
- Ability to undergo brain MRI with and without contrast
You will not qualify if you...
- Pregnant or breastfeeding/chestfeeding patients
- Impending life-threatening cerebral herniation syndrome
- Severe active comorbidities such as active infections needing IV treatment, immunosuppressive diseases, or HIV
- Severe heart disease (NYHA Class 3 or 4), lung disease (FEV1 < 50%), or uncontrolled diabetes
- Allergy to albumin
- Recent chemotherapy, bevacizumab, immunotherapy, tumor treating fields, or radiation therapy within specified timeframes
- Incomplete standard of care treatments including surgery and radiation
- Brainstem, cerebellum, or spinal cord tumors; active multifocal disease; extensive subependymal disease; tumor crossing midline or leptomeningeal disease
- Use of more than 4 mg/day dexamethasone within 2 weeks prior to infusion
- Worsening steroid myopathy
- Prior unrelated malignancy requiring active treatment (except certain skin cancers and cervical carcinoma in situ)
- Active autoimmune disease requiring immunomodulatory treatment within past 3 months
- For TMD subgroup: known allergies to silicone, polyurethane, or titanium
- Karnofsky Performance Score below 60% for salvage treatment
- Use of more than 4 mg/day dexamethasone within 2 weeks prior to subcutaneous 2141-V11 injection
- Severe active comorbidities or infections as above for salvage treatment
AI-Screening
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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. FRCPC
CONTACT
S
Stevie Threatt
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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