Recruiting
Phase 1
Phase 2

A2B395

Sponsor:

A2 Biotherapeutics Inc.

Code:

NCT06682793

Conditions

Solid Tumor, Adult

Colorectal Cancer

Non-Small Cell Lung

NSCLC (Non-small Cell Lung Cancer)

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A2B395

xT CDx with HLA-LOH assay

Study Details

Brief 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

Conditions

Solid Tumor, Adult

Colorectal Cancer

Non-Small Cell Lung

NSCLC (Non-small Cell Lung Cancer)

Cancer

Study ID

NCT06682793

Start date

May 22, 2025

Status verified date

Sep, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A2B395

Participants receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B395 intravenously on day 0

Interventions

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

Primary outcome measure

  • Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level [ Time Frame: From the time of Informed consent until 24 months (2 years) post A2B395 infusion ]
  • Phase 1: Recommended phase 2 dose (RP2D) [ Time Frame: 28 days post A2B395 infusion ]
  • Phase 2: The overall response rate (ORR) for patients [ Time Frame: 24 months post A2B395 infusion ]

Central Contacts and Locations

Central contacts

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Matthew Ulrickson, MD

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Rebecca Shatsky, MD

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90404

Contacts

Principal Investigator:

Deborah Wong, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Yanyan Lou, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33606

Contacts

Principal Investigator:

Kedar Kirtane, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Harry E. Fuentes Bayne, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Amberly Scott

amberly@wustl.edu

Principal Investigator:

Patrick Grierson, M.D., Ph.D.

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Salman Punekar, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Kai He, MD, PhD

Fred Hutch Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

Jennifer Specht, MD

More Information

Sponsor

A2 Biotherapeutics Inc.

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • CAR T Cell
  • Solid Tumors
  • Allogeneic
  • T Cell
  • EGFR
  • HLA-A2
  • Solid tumors expressing EGFR
  • CRC
  • Colorectal
  • Cell Therapy
  • Gene Therapy
  • Blocker
  • Cancer
  • NSCLC
  • Non small Cell Lung Cancer
  • Lung Cancer
  • renal cell carcinoma
  • RCC
  • Kidney Cancer
  • Renal cell cancer
  • Triple negative breast cancer
  • TNBC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by A2 Biotherapeutics Inc. on 2025-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.