Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05877599 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 3 of 5 entries Trial sites reduced: 23 → 20 locations · Eligibility criteria expanded, about 33 words · Secondary endpoints: details revised at 2 of 2 entries · 1 more Show 4 more changesShow less
    • Trial sites reduced: 23 → 20 locations
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
  2. Trial sites expanded: 18 → 23 locationsv29
  3. Re-verified, no change to tracked fieldsv28
  4. Primary endpoint(s) modified Trial arms changed: 3 → 1 · Interventions: Autologous, engineered T Cells targeting TP53 R175H (Biological) to NT-175 (Biological) · Eligibility criteria shortened, about 39 words · 3 morev27 Show 6 more changesShow less
    • Trial arms changed: 3 → 1
    • Interventions: Autologous, engineered T Cells targeting TP53 R175H (Biological) to NT-175 (Biological)
    • Eligibility criteria shortened, about 39 words
    • Secondary endpoints: 6 to 2
    • Study description shortened, about 20 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv26
  6. Primary completion pushed from Sep 1, 2028 to Jul 31, 2029v25
  7. Enrollment target: 46 to 45v24
  8. Re-verified, no change to tracked fieldsv23
  9. Enrollment target: 162 to 46 Completion date: Aug 1, 2039 to Jul 31, 2029 · Site details revised at 4 of 18 sitesv22 Show 2 more changesShow less
    • Completion date: Aug 1, 2039 to Jul 31, 2029
    • Site details revised at 4 of 18 sites
  10. Re-verified, no change to tracked fieldsv21
  11. Study sites: 17 to 18v20
  12. Study sites: 16 to 17v19
  13. Study sites: 15 to 16v18
  14. Study sites: 9 to 15v17
  15. Start date: Jul 27, 2023 to Jul 12, 2023v16
  16. Lead sponsor: Neogene Therapeutics, Inc. to AstraZeneca Primary completion date: Aug 2026 to Sep 1, 2028 · Completion date: Aug 2039 to Aug 1, 2039 · Site contacts updated at 3 of 9 sitesv15 Show 3 more changesShow less
    • Primary completion date: Aug 2026 to Sep 1, 2028
    • Completion date: Aug 2039 to Aug 1, 2039
    • Site contacts updated at 3 of 9 sites
  17. Re-verified, no change to tracked fieldsv14
  18. Study sites: 8 to 9v13
  19. Enrollment target: 24 to 162 Primary endpoints: 2 to 9 · Eligibility criteria expanded, about 6 words · Secondary endpoints revised (6) · 3 morev12 Show 6 more changesShow less
    • Primary endpoints: 2 to 9
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 72 words
    • Site contacts updated at 1 of 8 sites
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 7 to 8v11
  21. Study sites: 6 to 7v10
  22. Study sites: 5 to 6v9
  23. Eligibility criteria shortened, about 5 wordsv8 See this version in full on ClinicalTrials.gov ↗
  24. Eligibility criteria expanded, about 11 wordsv7 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 4 to 5v6
  26. Study sites: 3 to 4v5
  27. Study sites: 2 to 3 Start date changed from estimate of Aug 2023 to Jul 27, 2023v4 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2023 to Jul 27, 2023
  28. Study sites: 1 to 2v3
  29. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  30. 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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
and 6 more diseases
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
Trial Details
NCT Number NCT05877599
Lead Sponsor AstraZeneca
Conditions Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma, Breast Cancer, Other Solid Tumors, Ovarian Cancer, Myeloid Neoplasms (AML/MDS)
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov