Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT05736731
Active, not recruiting Phase 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

NCT05736731 · tracked via the Priya Life Science USA tracker
Sponsor
A2 Biotherapeutics Inc
Phase
Phase 1/2
Started
2023-04-28
Last updated
2025-04-25

Condition(s) studied

Solid Tumor, AdultSolid TumorPancreatic CancerPancreatic NeoplasmsPancreas CancerNon Small Cell Lung CancerNon Small Cell Lung Cancer RecurrentNon-Small Cell Squamous Lung CancerNSCLCNSCLC, RecurrentColorectal CancerColorectal NeoplasmsColorectal AdenocarcinomaCRCColorectal Cancer MetastaticCancer

Investigational drug(s) / intervention(s)

A2B530xT-Onco with HLA-LOH Assay

A2B530: Autologous logic-gated Tmod CAR T-cells

xT-Onco with HLA-LOH Assay: An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. 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 2. 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). 3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol 4. Has adequate organ function as described in the protocol 5. ECOG performance status of 0 to 1 6. Life expectancy of ≥3 months 7. Willing to comply with study schedule of assessments including long term safety follow up Key Exclusion Criteria: 1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative 2. Prior allogeneic stem cell transplant 3. Prior solid organ transplant 4. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion 5. Radiotherapy within 28 days of A2B530 infusion 6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months 7. 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. 8. Requires supplemental home oxygen 9. Females of childbearing potential who are pregnant or breastfeeding 10. 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

Primary outcome measure(s)

  • Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level — From the time of Informed consent until 24 months (2 years) post A2B530 infusion.
    Adverse Events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 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.
  • Phase 1: Recommended Phase 2 Dose (RP2D) — 21 days post A2B530 infusion
    The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.
  • Phase 2: The Overall Response Rate (ORR) for patients — 24 months post A2B530 infusion
    The ORR will be evaluated per RECIST v1.1 and assessed by independent central review.

Trial sites (8)

FacilityCityRegionStatus
Banner Health Gilbert Arizona
University of California San Diego La Jolla California
UCLA Medical Center Los Angeles California
Moffitt Cancer Center Tampa Florida
Mayo Clinic Rochester Rochester Minnesota
Washington University St Louis Missouri
NYU Langone Medical Center New York New York
MD Anderson Cancer Center Houston Texas

More A2 Biotherapeutics Inc. trials in the USA

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 Recruiting
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products Enrolling by invitation
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing Recruiting
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 Recruiting

Other trials for the same condition

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors Recruiting
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors Recruiting
Remote Temperature Monitoring of Patients At Risk for Developing Fever Recruiting
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics Recruiting
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05736731 on ClinicalTrials.gov ↗ ← All trials in the USA