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A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression

Study acronym: EVEREST-1
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 10 to 8 · Completion date: Dec 2028 to Dec 2026v21 Show 2 more changesShow less
    • Study sites: 10 to 8
    • Completion date: Dec 2028 to Dec 2026
  2. Site contacts updated at 3 of 10 sitesv20
  3. Site contacts updated at 7 of 10 sites Study title revisedv19 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Site contacts updated at 1 of 10 sitesv18
  5. Site details revised at 1 of 10 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Site contacts updated at 3 of 10 sitesv16
  2. Study sites: 11 to 10v15
  3. Study sites: 9 to 11v14
  4. Site contacts updated at 1 of 9 sitesv13
  5. Study sites: 8 to 9v12
  6. Site details revised at 1 of 8 sitesv11
  7. Re-verified, no change to tracked fieldsv10
  8. Site contacts updated at 1 of 8 sitesv9
  9. Site details revised at 1 of 8 sitesv8
  10. Site details revised at 1 of 8 sitesv7
  11. Site details revised at 1 of 8 sitesv6
  12. Study sites: 7 to 8v5
  13. Start date changed from estimate of Apr 2023 to Apr 28, 2023v4
  14. Site contacts updated at 1 of 7 sitesv3
  15. Trial status: Not Yet Recruiting to Recruiting Site details revised at 7 of 7 sites · Publications: 4 to 5v2 Show 2 more changesShow less
    • Site details revised at 7 of 7 sites
    • Publications: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this study is to test A2B530,an autologous logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the maximum or recommended dose of A2B530 that is safe for patients * Phase 2: Does the recommended dose of A2B530 kill the solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: * Enrollment and Apheresis in BASECAMP-1 (NCT04981119) * Preconditioning Lymphodepletion (PCLD) Regimen * A2B530 Tmod CAR T cells at the assigned dose
Trial Details
NCT Number NCT05736731
Lead Sponsor A2 Biotherapeutics Inc.
Collaborators: Tempus AI
Conditions Solid Tumor, Adult, Solid Tumor, Pancreatic Cancer, Pancreatic Neoplasms, Pancreas Cancer, Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Recurrent, Non-Small Cell Squamous Lung Cancer +8 more
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov