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NCT06051695 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by A2 Biotherapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 474
- Enrollment target
- 12
- Study locations
NCT06051695: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by A2 Biotherapeutics.
NCT06051695 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is actively recruiting participants, run by A2 Biotherapeutics. The registered enrollment target is 474 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (27% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06051695, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is actively recruiting participants, sponsored by A2 Biotherapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 474 participants
- Enrollment target
- 12
- Study locations
Study Summary
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
Primary Outcome
Adverse Events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version (CTCAE) 5.0 (or current version). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria described in the current protocol.
Conditions Studied
Interventions
- BIOLOGICAL A2B694
- BIOLOGICAL A2B543
- DIAGNOSTIC_TEST xT CDx with HLA-LOH Assay
Study Locations (12)
California
- UCSD Moores Cancer Center - La Jolla
- UCLA Medical Center - Los Angeles
- Stanford University - Stanford
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
Arizona
- Banner Health - Gilbert
Minnesota
- Mayo Clinic Rochester - Rochester
Missouri
- Washington University - St Louis
New York
- NYU Langone Medical Center - New York
Ohio
- The Ohio State University Comprehensive Cancer Center - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2024-04-03 |
| Est. Completion | 2029-06 |
| Phase | Phase 1 |
What NCT06051695 shows while recruiting
NCT06051695 is an interventional study that assigns participants to a tested intervention. The registered 474 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (27% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which A2B694 is the first listed.
NCT06051695 lists 12 locations in 9 states (California, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT06051695 about?
NCT06051695 is a clinical study titled "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". 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...
What is the current status of trial NCT06051695?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 474 participants. The study started on 2024-04-03. Estimated completion is 2029-06.
What conditions does trial NCT06051695 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Adult, NSCLC, Pancreas Cancer.
What interventions are being tested in trial NCT06051695?
The interventions under investigation include: A2B694 (BIOLOGICAL), A2B543 (BIOLOGICAL), xT CDx with HLA-LOH Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06051695?
This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06051695 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06051695's enrollment target sits among peer trials
474 84th of 454 higher than 371 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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