NCT07680439Toboroz2. fázis
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 28.
Rövid összefoglaló (regiszter, angolul)
This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG. To participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study. BCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 75 (tervezett)
- Első benyújtás
- 2026. jún. 22.
- Kezdés
- 2026. szept. 4.
- Elsődleges befejezés
- 2028. okt.
- Fő szponzor
- BrainChild Bio, Inc
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT07680439
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 75
- 2026. szept. 4. és az elsődleges befejezés (2028. okt.) között
- 6 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
- Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.
- Requirement of high or increasing doses of corticosteroids prior to participation.
Más betegség
- Evidence of metastatic disease.
- Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.
- Presence of an active malignancy other than DIPG.
- Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.
Laborértékek
- Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.
Egyéb
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or breastfeeding.
Kiket keres a vizsgálat
- Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.
- Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma
- Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.
- Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.
- Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.
- Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).
- Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.
- Participants of childbearing/fathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.
- Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.
- Participant must meet all other health and safety criteria defined in the study protocol.
- Participant and/or authorized legal representative willing to provide consent/assent for study participation, including participation in the 15-year long term follow up period.
Életkor a regiszterben: 1 év – 26 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (6)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Egyesült Államok | Toboroz |
| Lurie Children's Hospital | Chicago | Egyesült Államok | Toborzás még nem indult |
| Nationwide Children's Hospital | Columbus | Egyesült Államok | Toborzás még nem indult |
| Children's Hospital Los Angeles | Los Angeles | Egyesült Államok | Toborzás még nem indult |
| Children's Hospital of Philadelphia | Philadelphia | Egyesült Államok | Toboroz |
| Seattle Children's Hospital | Seattle | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.