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Clinical Trials in the USA / NCT06682793
Recruiting Phase 1/2

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

NCT06682793 · tracked via the Priya Life Science USA tracker
Sponsor
A2 Biotherapeutics Inc
Phase
Phase 1/2
Started
2025-05-22
Last updated
2025-09-09

Condition(s) studied

Solid Tumor, AdultColorectal CancerNon-Small Cell LungNSCLC (Non-small Cell Lung Cancer)CancerColon CancerRectal CancerLung CancerCRCHead and Neck Squamous Cell CancerHNSCCRenal Cell CarcinomaRCCKidney CancerTriple Negative Breast CancerTNBCColorectal Adenocarcinoma

Investigational drug(s) / intervention(s)

A2B395xT CDx with HLA-LOH assay

A2B395: Allogeneic logic-gated Tmod CAR T cells

xT CDx 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Key Inclusion Criteria: 1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02 by NGS (whenever possible from the primary site). 2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT. 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 A2B395 infusion 5. Radiotherapy within 28 days of A2B395 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. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year 9. Requires supplemental home oxygen 10. Females of childbearing potential who are pregnant or breastfeeding 11. 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 A2B395

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 A2B395 infusion
    Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.
  • Phase 1: Recommended phase 2 dose (RP2D) — 28 days post A2B395 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 A2B395 infusion
    The ORR will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and assessed by independent central review.

Trial sites (10)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
UCSD Moores Cancer Center La Jolla California Recruiting
UCLA Medical Center Los Angeles California Recruiting
Mayo Clinic Jacksonville Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University St Louis Missouri Recruiting
NYU Langone Health New York New York Recruiting
The Ohio State University Columbus Ohio Recruiting
Fred Hutch Cancer Center Seattle Washington Recruiting

More A2 Biotherapeutics Inc. trials in the USA

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
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 Active, not recruiting
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing Recruiting
A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products Enrolling by invitation

Other trials for the same condition

SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET Recruiting
Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy Active, not recruiting
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors Recruiting
A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) Recruiting
Evaluation of Improved Onboard Patient Imaging Active, not 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 NCT06682793 on ClinicalTrials.gov ↗ ← All trials in the USA