Biotel Research

• Enrollment was concentrated in the United States (224/272 participants), while 24 participants were enrolled in the EEA, including Belgium (4), Germany (4), and France (5).
• A sentinel cohort was added, and initiation of Part B enrollment was contingent on a favorable DSMB review of Part A safety and tolerability data.
• The screening period was extended to up to 35 days and the upper body-weight limit was increased by protocol amendment.
• Eligibility criteria were revised to permit participants with non-clinically significant bundle branch block, clarify malignancy and monoclonal-protein restrictions, and remove exclusion for a positive urine drug test.
• A France-specific exclusion criterion was added for persons under court protection, persons not affiliated with a social security system, and protected adults.
• The protocol clarified mTUG eligibility requirements and allowed investigator or medical-monitor assessment of whether concomitant autoimmune disease could confound clinical assessments.
• The Week 80 safety follow-up visit could be conducted by telephone after protocol amendment.

These findings describe the trial, not the service provider’s performance or responsibility.

• Enrollment was substantially below plan: 30 patients were enrolled globally versus approximately 132 planned.
• Part 1 enrolled 26 of 92 planned patients and Part 2 enrolled 4 of 40 planned patients; backfilling was not opened.
• The study operated at 13 sites: 4 in Spain, 2 in the United Kingdom, and 7 in the United States.
• Following the single response observed in cholangiocarcinoma during Part 1, Part 2 enrolled only patients with cholangiocarcinoma; no response was observed in Part 2.

These findings describe the trial, not the service provider’s performance or responsibility.