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Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Bu çalışma, genetik olarak tasarlanmış EGFR/IL13Rα2 hedefli CAR-T hücrelerinin doğrudan beyindeki tümör bölgesine uygulanmasını, nüksetmiş ya da ilerlemiş yüksek dereceli beyin tümörü (high-grade glioma) olan hastalarda incelemektedir. Çalışmaya, glioblastom ya da grade 4 astrositom tanısı olan, standart tedaviden sonra hastalığı ilerlemiş, tümöründe IL13Rα2 pozitifliği ve EGFR gen değişikliği bulunan 18 yaş ve üzeri hastalar alınmaktadır. Faz 1 aşamasında yürütülmektedir ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Main Inclusion Criteria * 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 radiographic progression consistent with grade 4 IDH-mutant astrocytoma. * 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 radiation therapy. * 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 T cells. Main Exclusion Criteria * 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).