Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1

StatusTerminated
PhasePhase 1
Started

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Record History

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  1. Trial terminated Sponsor's reason: Sponsor prioritization of other development portfolio Show 5 more changesShow less
    • Final enrollment: 52 participants (planned 120)
    • Primary completion date changed from estimate of Dec 31, 2026 to Sep 16, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 19 entries
    • Site details revised at 18 of 18 sites
  2. Site contacts updated at 1 of 18 sitesv9
  3. Eligibility criteria expanded, about 68 wordsv8
  4. Trial sites expanded: 14 → 18 locationsv7
  5. Site details revised at 2 of 14 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 1 of 14 sitesv5
  2. Site details revised at 1 of 14 sitesv4
  3. Study sites: 9 to 14v3 Show 4 more changesShow less
    • Eligibility criteria expanded, about 164 words
    • Study description expanded, about 26 words
    • Study title shortened, about 12 words
    • Study arms: 1 to 2
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 9
    • Start date changed from estimate of Dec 31, 2024 to Dec 19, 2024
    • Study title shortened, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.
Trial Details
NCT Number NCT06714591
Lead Sponsor SystImmune Inc.
Conditions
(from sponsor)		 Relapsed/Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov