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RECRUITING 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

NCT06051695 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 474 participants
Start Date 2024-04-03
Est. Completion 2029-06
Phase Phase 1

Sponsor

A2 Biotherapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06051695

The ClinicalTrials.gov registry entry for NCT06051695 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 474 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is A2 Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which A2B694 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06051695 reports 12 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Colorectal Cancer, Non Small Cell Lung Cancer, Solid Tumor, Adult, NSCLC, Pancreas Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06051695?

This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial