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New treatment option for Glioblastoma
Official title CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy
ClinicalTrials.gov ID: NCT06973096
What this study is testing
What is CART-EGFR-IL13Ra2 cells?
CART-EGFR-IL13Ra2 cells is an investigational medicine, being studied as a potential treatment for glioblastoma.
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 an open-label phase 1 study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma, without evidence of disease recurrence/progression following completion of initial radiotherapy.
- 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
- Step #1
- Signed informed consent form
- Male or females age ≥ 18 years.
- Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma (as defined by WHO 2021 Classification for CNS Tumors, including that...
- Patients must have undergone maximal safe resection of the tumor as per routine cancer care. Patients who have had a biopsy only are not eligible.
You likely can't join if
- Active hepatitis B or hepatitis C infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Tumors with enhancing disease involving the thalamus, brain stem or spinal cord.
- Tumors with an MGMT promoter methylation result of hypermethylated, methylated, low positive methylated, or indeterminate.
- Multifocal disease if ≥ 1 focus of tumor has not undergone maximal safe resection
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
See the full eligibility criteria
- Step #1
- Signed informed consent form
- Male or females age ≥ 18 years.
- Patients with newly diagnosed, EGFR-amplified, MGMT-unmethylated glioblastoma (as defined by WHO 2021 Classification for CNS Tumors, including that the tumor must be IDH wildtype). The tumor must also have...
- Patients must have undergone maximal safe resection of the tumor as per routine cancer care. Patients who have had a biopsy only are not eligible.
- Tumor tissue positive for wild-type EGFR amplification by Neogenomics Laboratories
- Karnofsky Performance Status ≥ 60%
- Patient scheduled to receive 60 Gy of radiotherapy. Either photon or proton therapy is acceptable. Step #1
- Active hepatitis B or hepatitis C infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Tumors with enhancing disease involving the thalamus, brain stem or spinal cord.
- Tumors with an MGMT promoter methylation result of hypermethylated, methylated, low positive methylated, or indeterminate.
- Multifocal disease if ≥ 1 focus of tumor has not undergone maximal safe resection
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
- History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
- Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
- Anticipated treatment plan that involves bevacizumab, any other systemic anti-neoplastic therapy, and/or tumor-treating fields as part of 1st line therapy. Step #2 Inclusion Criteria:
- Patient completed full course of radiotherapy to 60 Gy.
- No overt evidence of disease recurrence/progression post-radiotherapy confirmed by RANO 2.0 criteria.
- Karnofsky Performance Status ≥ 60%
- Adequate organ function defined as:
- Serum creatinine ≤ 1.5x ULN or estimated creatinine clearance ≥ 30 mL/min and not on dialysis
- ALT/AST ≤ 3 x ILN
- Total bilirubin ≤ 2.0 mg/dl, except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome (≤ 3.0 mg/Dl)
- Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO/MUGA
- Must have minimum level of pulmonary reserve defined as \> 92% on room air Step #2 Exclusion Criteria:
- Any active, uncontrolled infection.
- Severe, active co-morbidity that, in the opinion of the physician-investigator, would preclude participation in this study.
- Clinical or neurological decline related to disease and/or radiotherapy that, in the opinion of the physician-investigator, would preclude participation in this study.
- Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods.
- Receipt of prior bevacizumab therapy for their newly diagnosed glioblastoma.
- Receipt of temozolomide for their newly diagnosed glioblastoma.
- Anticipated post-radiotherapy maintenance treatment that includes tumor treating fields, bevacizumab, or any other anti-neoplastic therapies.
- Enrollment in any other clinical trial for the treatment of their newly diagnosed glioblastoma.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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 Philadelphia, Pennsylvania, 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.