RecruitingPhase 1

Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc

United States36 participantsStarted 2022-09-02

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 (MRI) criteria. Disseminated GBM down the spinal cord is not allowed. Must have previously undergone resection or biopsy at initial diagnosis.
✓. Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
✓. No current or previous exposure to antiangiogenic agents, such as bevacizumab.
✓. Female subjects 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 treatment discontinuation.
✓. Male subjects 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 male subject receives multiple infusions, they must remain on contraception throughout the duration and 3 months after the last cell infusion therapy.
✓. The subject is willing and able to comply with study procedures based on the judgment of the investigator.

Exclusion criteria

✕. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
✕. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.

What they're measuring

Number of participants with adverse event

Timeframe: Up to 10 weeks

Cytokine Release Syndrome

Timeframe: Up to 10 weeks

Neurotoxicity

Timeframe: Up to 10 weeks

Trial details

NCT IDNCT05366179

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05-30

Contact for this trial

Catherine Cheng

919-445-4208 UNCImmunotherapy@med.unc.edu

View on ClinicalTrials.gov More Glioblastoma Multiforme trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 (MRI) criteria. Disseminated GBM down the spinal cord is not allowed. Must have previously undergone resection or biopsy at initial diagnosis.
✓. Must have undergone at least 4005 cGy of radiation with concurrent temozolomide.
✓. No current or previous exposure to antiangiogenic agents, such as bevacizumab.
✓. Female subjects 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 treatment discontinuation.
✓. Male subjects 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 male subject receives multiple infusions, they must remain on contraception throughout the duration and 3 months after the last cell infusion therapy.
✓. The subject is willing and able to comply with study procedures based on the judgment of the investigator.

Exclusion criteria

✕. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study).
✕. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.