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New treatment option for Glioblastoma Multiforme
Official title Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
ClinicalTrials.gov ID: NCT05366179
What this study is testing
What is CAR.B7-H3T cells infusion?
CAR.B7-H3T cells infusion is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Karnofsky score of \> 60%
- Diagnosis or recurrent supratentorial- or infra-tentorial glioblastoma multiforme (GBM) (World Health Organization 2016 or 2021) based on Response...
- Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
- No current or previous exposure to antiangiogenic agents, such as bevacizumab.
- Female people of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception...
You likely can't join if
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- Active infection with HIV, hepatitis B virus, hepatitis C virus (HCV). Note: To meet eligibility people are required to be negative for HIV antibody...
- Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.
- Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
- Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.
See the full eligibility criteria
- Karnofsky score of \> 60%
- Diagnosis or recurrent supratentorial- or infra-tentorial glioblastoma multiforme (GBM) (World Health Organization 2016 or 2021) based on Response assessment in neuro-oncology criteria (RANO) magnetic resonance imaging...
- Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
- No current or previous exposure to antiangiogenic agents, such as bevacizumab.
- Female people of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study...
- Male people with female partners must have had a prior vasectomy or agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the cell infusion therapy. If a...
- The subject is willing and able to comply with study procedures based on the judgment of the investigator.
- Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Active infection with HIV, hepatitis B virus, hepatitis C virus (HCV). Note: To meet eligibility people are required to be negative for HIV antibody, negative for HTLV1 and 2 antibodies, negative for Hepatitis B surface...
- Contraindication to MRI contrast agents or an inability to undergo MRI scans due to MRI non-compatible implanted materials.
- Prior exposure to chimeric antigen receptor T cell therapy for treatment of glioblastoma.
- Evidence of disseminated disease involving the brainstem, cerebellum or spinal cord.
- Previously implanted carmustine wafers or brachytherapy for the treatment of glioma.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.