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New treatment option for Recurrent Astrocytoma, IDH-Mutant, Grade 4
Official title Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
ClinicalTrials.gov ID: NCT07544992
What this study is testing
What is Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells?
Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent astrocytoma, idh-mutant, grade 4.
Also referred to as Autologous Anti-EGFR/Anti-IL13Ra2 CAR T-cells, Autologous Anti-EGFR/IL13Ra2 CAR 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 phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy.
- 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
- Main Documented informed consent of the participant and/or legally authorized representative.
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.
- Age 18 years and older.
- KPS ≥ 70%, ECOG ≤ 2 (Appendix A).
- Life expectancy ≥ 4 weeks.
You likely can't join if
- Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.
- Participant has not yet recovered from toxicities of prior therapy.
- Participant has received any live vaccine within 30 days prior to enrollment.
- Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
See the full eligibility criteria
- Main Documented informed consent of the participant and/or legally authorized representative.
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.
- Age 18 years and older.
- KPS ≥ 70%, ECOG ≤ 2 (Appendix A).
- Life expectancy ≥ 4 weeks.
- Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has...
- Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line...
- COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):
- IL13Rα2+ expression by IHC \> 20, and
- EGFR gene-altered by NGS or FISH analysis
- No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.
- WBC \> 2000 /dl (or ANC ≥ 1,000/mm3)
- Platelets ≥ 75,000/mm3
- Hemoglobin \> 9g/dL
- Total bilirubin ≤ 1.5x ULN
- AST ≤ 2.5x ULN
- ALT ≤ 2.5x ULN
- Serum creatinine ≤1.6 mg/dL
- O2 saturation ≥ 95% on room air.
- Seronegative for HIV Ag/Ab combo, HCV, and active HBV
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR...
- Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.
- Participant has not yet recovered from toxicities of prior therapy.
- Participant has received any live vaccine within 30 days prior to enrollment.
- Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- Clinically significant uncontrolled illness.
- Active autoimmune disease requiring systemic immunosuppressive therapy
- Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).
- Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.
- Other active malignancy.
- Females only: Pregnant or breastfeeding.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.
- Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, 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 Duarte, California, 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.