{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":null,"indication":null,"name":"NCT03933735","nct_id":"NCT03933735","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03933735. 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":"Up to 15 cohorts of participants receiving sequentially ascending doses of TNB-383B are planned until maximum tolerated dose is reached or recommended phase 2 dose is identified.","label":"Arm A: Dose Escalation","type":"EXPERIMENTAL"},{"description":"An expansion cohort will be enrolled at the recommended phase 2 Dose A.","label":"Arm B: Dose Expansion Dose A","type":"EXPERIMENTAL"},{"description":"An expansion cohort will be enrolled at the recommended phase 2 Dose B.","label":"Arm B: Dose Expansion Dose B","type":"EXPERIMENTAL"},{"description":"An expansion cohort will be enrolled at the recommended phase 2 Dose A.","label":"Arm E: Monotherapy Once Every 4 Weeks (Q4W)","type":"EXPERIMENTAL"},{"description":"An expansion cohort will be enrolled at the recommended phase 2 Dose C.","label":"Arm F: Monotherapy Dose C","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-05","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":220,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"TNB-383B","otherNames":[],"type":"DRUG"}],"last_update":"2026-02-06","lead_sponsor":"AbbVie","official_title":"A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2026-05","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants with Dose-limiting toxicities (DLT)","timeFrame":"Day 21"},{"measure":"Number of Participants with Adverse Events (AEs) and/or Serious Adverse Events (SAEs)","timeFrame":"Up to 3 Years"},{"measure":"Maximum Observed Plasma Concentration of TNB-383B (Cmax)","timeFrame":"Week 12"},{"measure":"Time to Cmax of TNB-383B (Tmax)","timeFrame":"Week 12"},{"measure":"Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUClast)","timeFrame":"Week 12"},{"measure":"Clearance (CL) of TNB-383B","timeFrame":"Week 12"},{"measure":"Terminal Phase Elimination Rate Constant (Beta) of TNB-383B","timeFrame":"Week 12"},{"measure":"Terminal Half-Life (t1/2) of TNB-383B","timeFrame":"Week 12"},{"measure":"Number of Participants with of Anti-drug Antibody (ADA)","timeFrame":"Up to Month 48"}],"references":[{"citation":"D'Souza A, Shah N, Rodriguez C, Voorhees PM, Weisel K, Bueno OF, Pothacamury RK, Freise KJ, Yue S, Ross JA, Polepally AR, Talati C, Lee S, Jin Z, Buelow B, Vij R, Kumar S. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen x CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. J Clin Oncol. 2022 Nov 1;40(31):3576-3586. doi: 10.1200/JCO.22.01504. Epub 2022 Aug 27.","pmid":"36029527","type":"DERIVED"}],"start_date":{"date":"2019-06-24","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of TNB-383B in Participants With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03933735"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03933735"}