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

Study acronym: EVEREST-2
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 12 sitesv20
  2. Site contacts updated at 3 of 12 sitesv19
  3. Site contacts updated at 1 of 12 sitesv18
  4. Site contacts updated at 1 of 12 sitesv17
  5. Enrollment target: 230 to 474 Study sites: 13 to 12 · Interventions: A2B694 (Biological), xT CDx with HLA-LOH Assay (Diagnostic Test) to A2B543 (Biological), A2B694 (Biological), xT CDx with HLA-LOH Assay (Diagnostic Test) · Secondary endpoints revised (2) · 4 morev16 Show 7 more changesShow less
    • Study sites: 13 to 12
    • Interventions: A2B694 (Biological), xT CDx with HLA-LOH Assay (Diagnostic Test) to A2B543 (Biological), A2B694 (Biological), xT CDx with HLA-LOH Assay (Diagnostic Test)
    • Secondary endpoints revised (2)
    • Study description expanded, about 26 words
    • Study arms: 1 to 2
    • Eligibility criteria shortened, about 4 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 11 to 13v15
  2. Study sites: 10 to 11v14
  3. Site contacts updated at 7 of 10 sites Study title revisedv13 Show 1 more changeShow less
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 9 to 10v12
  5. Site contacts updated at 1 of 9 sitesv11
  6. Site details revised at 1 of 9 sitesv10
  7. Study sites: 8 to 9 Start date changed from estimate of Mar 2024 to Apr 3, 2024v9 Show 1 more changeShow less
    • Start date changed from estimate of Mar 2024 to Apr 3, 2024
  8. Study sites: 9 to 8v8
  9. Site details revised at 1 of 9 sitesv7
  10. Study sites: 10 to 9v6
  11. Site details revised at 2 of 10 sitesv5
  12. Trial status: Not Yet Recruiting to Recruiting Site details revised at 10 of 10 sitesv4 Show 1 more changeShow less
    • Site details revised at 10 of 10 sites
  13. Publications revised (4)v3 See this version in full on ClinicalTrials.gov ↗
  14. Secondary endpoints: details revised at 1 of 2 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A2 Biotherapeutics Inc.
5 trials monitored
See all monitored trials
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
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
and 3 more diseases
The goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill 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 Tmod CAR T cells at the assigned dose
Trial Details
NCT Number NCT06051695
Lead Sponsor A2 Biotherapeutics Inc.
Collaborators: Tempus AI
Conditions Solid Tumor, Adult, Colorectal Cancer, NSCLC, Non Small Cell Lung Cancer, NSCLC, Recurrent, Non-Small Cell Squamous Lung Cancer, Pancreas Cancer, Pancreatic Neoplasm +12 more
Enrollment 474 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov