RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

Quick Facts

Study Start:2025-03-31
Study Completion:2030-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06682793

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
  2. 2. Prior allogeneic stem cell transplant
  3. 3. Prior solid organ transplant
  4. 4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
  5. 5. Radiotherapy within 28 days of A2B395 infusion
  6. 6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
  7. 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. 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. 9. Requires supplemental home oxygen
  10. 10. Females of childbearing potential who are pregnant or breastfeeding
  11. 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

Contacts and Locations

Study Contact

Clinical Trials
CONTACT
310-431-9180
ClinicalTrials@a2bio.com

Principal Investigator

John Welch, MD, PhD
STUDY_DIRECTOR
A2 Biotherapeutics

Study Locations (Sites)

UCSD Moores Cancer Center
La Jolla, California, 92093
United States
UCLA Medical Center
Los Angeles, California, 90404
United States
Moffitt Cancer Center
Tampa, Florida, 33606
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington Unversity
Saint Louis, Missouri, 63110
United States
NYU Langone Medical Center
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: A2 Biotherapeutics Inc.

  • John Welch, MD, PhD, STUDY_DIRECTOR, A2 Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-31
Study Completion Date2030-03-31

Study Record Updates

Study Start Date2025-03-31
Study Completion Date2030-03-31

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Solid Tumor, Adult
  • Colorectal Cancer
  • Non-Small Cell Lung
  • NSCLC (Non-small Cell Lung Cancer)
  • Cancer
  • Colon Cancer
  • Rectal Cancer
  • Lung Cancer
  • CRC
  • Head and Neck Squamous Cell Cancer
  • HNSCC
  • Renal Cell Carcinoma
  • RCC
  • Kidney Cancer
  • Triple Negative Breast Cancer
  • TNBC
  • Colorectal Adenocarcinoma