NCT03638167Befejeződött1. fázis
EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors
Phase 1 Study of EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric Central Nervous System Tumors
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 17.
Rövid összefoglaló (regiszter, angolul)
This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells that are lentivirally transduced to express an EGFR806 specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor cavity or the ventricular system in children and young adults with recurrent or refractory EGFR-positive CNS tumors. The primary objectives of this protocol are to evaluate the feasibility, safety, and tolerability of CNS-delivered fractionated CAR T cell infusions employing intra-patient dose escalation. Subjects with supratentorial tumors will receive sequential EGFR806-specific CAR T cells delivered into the tumor resection cavity, subjects with infratentorial tumors will receive sequential CAR T cells delivered into the fourth ventricle, and subjects with leptomeningeal disease will receive sequential CAR T cells delivered into the lateral ventricle. The secondary objectives are to assess CAR T cell distribution within the cerebrospinal fluid (CSF), the extent to which CAR T cells egress into the peripheral circulation, and EGFR expression at recurrence of initially EGFR-positive tumors. Additionally, tumor response will be evaluated by magnetic resonance imaging (MRI) and CSF cytology. The exploratory objectives are to analyze CSF specimens for biomarkers of anti-tumor CAR T cell presence and functional activity.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 11 (tényleges)
- Első benyújtás
- 2018. aug. 15.
- Kezdés
- 2019. márc. 19.
- Elsődleges befejezés
- 2023. dec. 22.
- Fő szponzor
- Seattle Children's Hospital
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT03638167
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 11
- 2019. márc. 19. és az elsődleges befejezés (2023. dec. 22.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Receiving any anti-cancer agents or chemotherapy
Más betegség
- Presence of ≥ Grade 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention
- Presence of primary immunodeficiency/bone marrow failure syndrome
- Presence of active malignancy other than the primary CNS tumor under study
- Presence of active severe infection
- Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol
Egyéb
- Diagnosis of classic diffuse intrinsic pontine glioma (DIPG)
- Presence of clinical and/or radiographic evidence of impending herniation
- Pregnant or breastfeeding
- Subject and/or authorized legal representative unwilling to provide consent/assent for participation in the 15 year follow up period
Kiket keres a vizsgálat
- Age ≥ 15 and ≤ 26 years
- Histologically diagnosed EGFR positive Central Nervous System (CNS) tumor
- Evidence of refractory or recurrent CNS disease for which there is no standard therapy
- Able to tolerate apheresis or apheresis product available for use in manufacturing
- CNS reservoir catheter, such as an Ommaya or Rickham catheter
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky score ≥ 60
- If patient does not have previously obtained apheresis product, patient must have recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment:
- ≥ 7 days post last chemotherapy/biologic therapy administration
- 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy
- Must be at least 30 days from most recent cellular infusion
- All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg/m2/day. Corticosteroid physiologic replacement therapy is allowed.
- Adequate organ function
- Adequate laboratory values
- Subjects of childbearing/fathering potential must agree to use highly effective contraception
Életkor a regiszterben: 1 év – 26 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Seattle Children's Hospital | Seattle | Egyesült Államok | Ismeretlen állapot |
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