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A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

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

Record History

  1. Study sites: 9 to 10v10
  2. Study sites: 8 to 9v9
  3. Study sites: 7 to 8v8
  4. Study sites revised (7)v7 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (7)v6 See this version in full on ClinicalTrials.gov ↗
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  1. Study sites: 6 to 7 Start date changed from estimate of Mar 31, 2025 to May 22, 2025v5 Show 1 more changeShow less
    • Start date changed from estimate of Mar 31, 2025 to May 22, 2025
  2. Trial status: Not Yet Recruiting to Recruiting Site details revised at 6 of 6 sitesv4 Show 1 more changeShow less
    • Site details revised at 6 of 6 sites
  3. Re-verified, no change to tracked fieldsv3
  4. Study Identification, Study Status, Oversight, Conditionsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
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 4 more diseases
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 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 in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose
Trial Details
NCT Number NCT06682793
Lead Sponsor A2 Biotherapeutics Inc.
Conditions Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer, Rectal Cancer, Lung Cancer +9 more
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov