NCT05736731Active, not recruitingPhase 1/2
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
A Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B530, an Autologous Logic-gated Tmod™ Chimeric Antigen Receptor T Cell (CAR T), in Heterozygous HLA-A*02 Adult Subjects With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 30 Jan 2023
- Start date
- 28 Apr 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- A2 Biotherapeutics Inc.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT05736731
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 160
- From 28 Apr 2023 to the primary completion date, 31 Dec 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Radiotherapy within 28 days of A2B530 infusion
Other illness
- Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
- Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion
- Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
- Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated.
Other
- Requires supplemental home oxygen
- Females of childbearing potential who are pregnant or breastfeeding
- Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B530
Who the study is looking for
- Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy
- Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of \>1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).
- Received previous required therapy for the appropriate solid tumor disease as described in the protocol
- Has adequate organ function as described in the protocol
- ECOG performance status of 0 to 1
- Life expectancy of ≥3 months
- Willing to comply with study schedule of assessments including long term safety follow up
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Banner Health Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| UCLA Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| NYU Langone Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.