{"preliminary_commentary":{"by_channel":{"x_thread":3,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["CARv3-TEAM-E"]],"indication":"glioblastoma","name":"INCIPIENT","nct_id":"NCT05660369","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=incipient-nct05660369. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"* Participant enrollment will be staggered by 30 days for up to 3 participants.\n* Participants will receive 1 infusion of CARv3-TEAM-E.\n* Phase will be expanded up to 6 participants if any Dose-Limiting Toxicities DLTs occur.\n* After all participants have been enrolled, there will be an evaluation made by the Data Safety Monitoring Board (DSMB) and the FDA to determine the safety of enrollment into additional arms.","label":"Safety Run-In Phase","type":"EXPERIMENTAL"},{"description":"* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.\n* Rituximab will be administered 5-10 days prior to infusion.\n* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.\n* CARv3-TEAM-E will be administered via Ommaya on D0\n* Participants will be followed for 2 years post-treatment.\n* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.","label":"Arm 1: Recurrent Glioblastoma (GBM), EGFRvIII Positive","type":"EXPERIMENTAL"},{"description":"* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.\n* Rituximab will be administered 5-10 days prior to infusion.\n* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.\n* CARv3-TEAM-E will be administered via Ommaya on D0\n* Participants will be followed for 2 years post-treatment.\n* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.","label":"Arm 2: Newly Diagnosed GBM, EGFRvIII Positive","type":"EXPERIMENTAL"},{"description":"* Participants will undergo a leukapheresis procedure, or collection of mononuclear T cells via peripheral blood draw.\n* Rituximab will be administered 5-10 days prior to infusion.\n* Lymphodepletion chemotherapy treatment will occur 5 days prior to infusion.\n* CARv3-TEAM-E will be administered via Ommaya on D0\n* Participants will be followed for 2 years post-treatment.\n* Participants who are deriving clinical benefit and have sufficient product can be retreated with up to 5 additional doses.","label":"Arm 3: Recurrent GBM, EGFRvIII Negative","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-09-01","type":"ESTIMATED"},"conditions":["Glioblastoma","Malignant Glioma","Recurrent Glioblastoma","Recurrent Glioma"],"enrollment":{"count":21,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"CARv3-TEAM-E T cells","otherNames":["Autologous T lymphocyte"],"type":"DRUG"}],"last_update":"2026-07-14","lead_sponsor":"Marcela V. Maus, M.D.,Ph.D.","official_title":"INCIPIENT: INtraventricular CARv3-TEAM-E T Cells for PatIENTs With GBM","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2026-09-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of Adverse Events (AEs)","timeFrame":"From Day 0 to 2 years post-treatment"},{"measure":"Number of Dose-Limiting Toxicities (DLTs)","timeFrame":"up to 6 months"}],"references":[{"citation":"Choi BD, Gerstner ER, Frigault MJ, Leick MB, Mount CW, Balaj L, Nikiforow S, Carter BS, Curry WT, Gallagher K, Maus MV. Intraventricular CARv3-TEAM-E T Cells in Recurrent Glioblastoma. N Engl J Med. 2024 Apr 11;390(14):1290-1298. doi: 10.1056/NEJMoa2314390. Epub 2024 Mar 13.","pmid":"38477966","type":"DERIVED"}],"start_date":{"date":"2023-03-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CARv3-TEAM-E T Cells in Glioblastoma","url":"https://clinicaltrials.gov/study/NCT05660369"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/incipient-nct05660369"}