{"preliminary_commentary":{"by_channel":{"youtube":1,"x_thread":1,"bluesky_thread":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"TRIgnite-1","nct_id":"NCT05862012","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=trignite-1-nct05862012. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants with R/R MM is administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study","label":"Part 1: Dose Escalation","type":"EXPERIMENTAL"},{"description":"Dose expansion cohorts are initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study.","label":"Part 2: Dose Expansion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-07","type":"ESTIMATED"},"conditions":["Relapsed/Refractory Multiple Myeloma"],"enrollment":{"count":200,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"ISB 2001","otherNames":[],"type":"DRUG"},{"name":"ISB 2001","otherNames":[],"type":"DRUG"}],"last_update":"2026-04-01","lead_sponsor":"Ichnos Sciences SA","official_title":"A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2027-07","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)","timeFrame":"Up to 18 months"},{"measure":"Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)","timeFrame":"Up to 28 days"}],"references":[{"citation":"Chandralayam Ayyappa Menon V, Matsuura T, Holkova B, Gudi GS, Drake A, Pihlgren M, van der Graaf PH, Gn S, Garton A, Perro M, Konto C, Pacaud L. Clinical Validation of a QSP Model for ISB 2001, a Trispecific T Cell Engager to Support Optimal FIH Study Design in RRMM Patients. Clin Pharmacol Ther. 2026 Aug;120(2):452-464. doi: 10.1002/cpt.70319. Epub 2026 May 28.","pmid":"42206665","type":"DERIVED"},{"citation":"Carretero-Iglesia L, Hall OJ, Berret J, Pais D, Estoppey C, Chimen M, Monney T, Loyau J, Dreyfus C, Macoin J, Perez C, Menon V, Gruber I, Laurendon A, Caro LN, Gudi GS, Matsuura T, van der Graaf PH, Blein S, Mbow ML, Croasdale-Wood R, Srivastava A, Dyson MR, Matthes T, Kaya Z, Edwards CM, Edwards JR, Maiga S, Pellat-Deceunynck C, Touzeau C, Moreau P, Konto C, Drake A, Zhukovsky EA, Perro M, Pihlgren M. ISB 2001 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells. Nat Cancer. 2024 Oct;5(10):1494-1514. doi: 10.1038/s43018-024-00821-1. Epub 2024 Sep 11.","pmid":"39261676","type":"DERIVED"}],"start_date":{"date":"2023-11-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)","url":"https://clinicaltrials.gov/study/NCT05862012"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/trignite-1-nct05862012"}