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New treatment option for Glioblastoma Multiforme
Official title IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Adult Glioblastoma
ClinicalTrials.gov ID: NCT05353530
What this study is testing
What is Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells?
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioblastoma multiforme.
Also referred to as 8R-70CAR T cells.
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
- This is a phase I study to assess the safety and feasibility of IL-8 receptor modified patient-derived activated CD70 CAR T cell therapy in CD70+ adult 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 to 80
You may be able to join if
- (Adult GBM):
- Age ≥ 18 years
- Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies...
- The tumor must have a supratentorial component
- CD70 positive (≥5%, 1+) Tumor expression will be scored on a scale of 0 to 3 staining intensity: 0 = Negative
You likely can't join if
- (Adult GBM):
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3years. (In situ cancer are permissible)
- Metastases detected below the tentorium or beyond the cranial vault
- Leptomeningeal disease beyond the cranial vault. (Focal, adjacent and leptomeningeal involvement is allowable at the discretion of the PI).
- Recurrent or multifocal malignant gliomas.
- The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician.
See the full eligibility criteria
- (Adult GBM):
- Age ≥ 18 years
- Newly-diagnosed de novo GBM based on the absence of previous history of brain tumor (WHO Grade IV glioma) by histopathology or molecular studies. (secondary GBM not eligible)
- The tumor must have a supratentorial component
- CD70 positive (≥5%, 1+) Tumor expression will be scored on a scale of 0 to 3 staining intensity: 0 = Negative
- = Low level
- = Moderate level
- = High level
- The criteria for inclusion will be at least 5% of the cells scoring 1+ staining intensity (\> 5%, 1+).
- Surgical resection of tumors with less than 3cm x 3cm (9 cm2) residual enhancing tumor as a product of longest perpendicular planes by MRI or biopsy only for tumor measuring less than 3cm x 3cm
- Karnofsky Performance Status (KPS) of \> 70%
- CBC with differential with adequate bone marrow function as defined below:
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
- Platelet count ≥ 100,000 cells/mm3.
- Hemoglobin ≥ 10 g/dl. (The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.)
- Adequate renal function as defined below:
- BUN ≤ 25 mg/dl
- Creatinine ≤ 1.7 mg/dl
- Adequate hepatic function as defined below:
- Bilirubin ≤ 2.0 mg/dl
- ALT ≤ 5 times institutional upper limits of normal for age
- AST ≤ 5 times institutional upper limits of normal for age
- Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative.
- For females of childbearing potential, a negative serum pregnancy test at enrollment.
- Women of childbearing potential (WOCBP) must be willing to use an acceptable contraceptive method to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.
- Males with female partners of childbearing potential must agree to practice adequate contraceptive methods throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.
- (Adult GBM):
- Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3years. (In situ cancer are permissible)
- Metastases detected below the tentorium or beyond the cranial vault
- Leptomeningeal disease beyond the cranial vault. (Focal, adjacent and leptomeningeal involvement is allowable at the discretion of the PI).
- Recurrent or multifocal malignant gliomas.
- The patient is not a candidate for cellular therapy as assessed by the study bone marrow transplant physician.
- Known immunosuppressive disease or human immunodeficiency virus (HIV) infection. Rationale: The need to exclude patients with the immunosuppressive disease or human
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the initiation of XRT/TMZ.
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the initiation of XRT/TMZ.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Patients with an autoimmune disease requiring medical management with immunosuppressants.
- Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.
- Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.
- Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant.
- Patients treated on any other therapeutic clinical protocols within 30 days prior to enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, 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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, 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.