Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT05734560

D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Led by Darell Bigner · Updated on 2025-10-06

50

Participants Needed

1

Research Sites

268 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 research study is to determine the safety and efficacy of administering a single intracerebral (within the brain) dose of investigational compounds called D2C7-immunotoxin (IT) and 2141-V11 in residual disease (within tumor margins) after surgery, followed by later repeated injections of 2141-V11 in the subcutaneous area (under the skin) around the lymph nodes of the head and neck for adults newly diagnosed with a type of cancerous brain tumor called glioblastoma. The word "investigational" means the study drugs are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA).

CONDITIONS

Official Title

D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of study entry
  • Newly diagnosed supratentorial glioblastoma, WHO grade 4, IDH wildtype, MGMT unmethylated with residual non-contrast enhancing disease ≤ 3 cm suitable for catheter placement
  • Completed standard radiation therapy with temozolomide and 2 cycles of post-radiation adjuvant temozolomide, or radiation therapy alone if MGMT status known before radiation
  • Karnofsky Performance Score greater than 70%
  • Able to undergo brain MRI with and without contrast
  • Hemoglobin level at least 9 g/dl before catheter placement
  • Platelet count at least 100,000/µL unsupported; at least 125,000/µL required for biopsy and catheter insertion (platelet transfusion allowed)
  • Neutrophil count at least 1000 before catheter placement
  • Creatinine level no more than 1.5 times normal range before catheter placement
  • Total bilirubin no more than 1.5 times upper limit of normal before catheter placement (up to 3.0 times allowed for Gilbert's Syndrome)
  • AST and ALT no more than 2.5 times upper limit of normal
  • PT and PTT no more than 1.2 times normal before biopsy; anticoagulation allowed with INR less than 2.0 if on warfarin
  • Patient or partner is non-childbearing or agrees to use approved birth control methods
  • Able to read, understand, and sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding individuals
  • Life-threatening brain herniation syndrome as assessed by neurosurgeon
  • Active severe medical conditions including active infection requiring IV treatment, HIV infection, severe heart disease (NYHA Class 3 or 4), lung disease with FEV1 less than 50%, uncontrolled diabetes, albumin allergy, hepatitis C positive status
  • Major medical or psychiatric illnesses preventing treatment completion
  • Prior therapies for glioblastoma except surgery, radiation, and temozolomide as specified
  • Radiation therapy and temozolomide less than 11 weeks before starting D2C7-IT infusion
  • Tumor involvement in brainstem, cerebellum, spinal cord, multifocal disease, crossing midline, extensive subependymal or leptomeningeal disease
  • Use of more than 4 mg dexamethasone daily within 2 weeks before D2C7-IT infusion
  • Worsening steroid myopathy with progressive muscle weakness and atrophy
  • Prior unrelated malignancy requiring current active treatment except certain skin and cervical cancers
  • Active autoimmune disease needing systemic immunomodulatory treatment within past 3 months
  • Inability to undergo MRI due to obesity, metal implants, or severe contrast allergies (mild allergies allowed with premedication)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

D

Daniel Landi, 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

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