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A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

StatusRecruiting
PhasePhase 1/2
SponsorDren Bio
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv27
  2. Enrollment increased: 69 → 200 participants
    • Site details revised at 1 of 37 sites
    v26
  3. Enrollment target: 69 to 200
    • Eligibility criteria shortened, about 12 words
    • Site details revised at 37 of 37 sites
    v25
  4. Study sites: 36 to 37v24
  5. Collaborators shortened, about 5 wordsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Study sites: 35 to 36v22
  2. Site details revised at 2 of 35 sitesv21
  3. Re-verified, no change to tracked fieldsv20
  4. Study sites: 34 to 35v19
  5. Study sites revised (34)
    • Collaborator revised
    v18
  6. Primary completion date: Dec 2024 to Dec 2026
    • Study completion date: Dec 2025 to Dec 2026
    • Site details revised at 3 of 34 sites
    v17
  7. Site details revised at 1 of 34 sitesv16
  8. Site details revised at 5 of 34 sitesv15
  9. Study sites: 32 to 34v14
  10. Site details revised at 1 of 32 sitesv13
  11. Site details revised at 5 of 32 sitesv12
  12. Study sites: 20 to 32v11
  13. Study sites: 17 to 20v10
  14. Site details revised at 4 of 17 sites
    • Collaborators: 2 to 1
    v9
  15. Study sites: 14 to 17v8
  16. Study sites: 11 to 14v7
  17. Primary endpoints: 5 to 4
    • Study sites: 10 to 11
    • Eligibility criteria expanded, about 123 words
    v6
  18. Site details revised at 1 of 10 sitesv5
  19. Site details revised at 1 of 10 sitesv4
  20. Site details revised at 1 of 10 sitesv3
  21. Study sites: 9 to 10v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Dren Bio
4 trials monitored
See 1 trial at risk
Leukemia
2,948 trials monitored
See 180 trials at risk
Non-Hodgkin Lymphoma
2,013 trials monitored
See 115 trials at risk
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
Trial Details
NCT Number NCT05475925
Lead Sponsor Dren Bio
Conditions
(from sponsor)		 LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma, Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Aggressive NK Cell Leukemia, Systemic EBV1 T-cell Lymphoma, if CD8 Positive, Hydroa Vacciniforme-Like Lymphoproliferative Disorder +5 more
Related terms Enteropathy-Associated T-Cell Lymphoma, Leukemia, Leukemia, Large Granular Lymphocytic, Lymphoma, Lymphoma, Extranodal NK-T-Cell, Subcutaneous panniculitis-like T-cell lymphoma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov