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 · NCT06682793 · Interventional (participants receive a specific treatment) · Lead sponsor: A2 Biotherapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
A2B395xT CDx with HLA-LOH assay
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Key Inclusion Criteria:
- 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).
- 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.
- 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
- Key
Exclusion criteria
- Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
- Radiotherapy within 28 days of A2B395 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
- 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
- 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 A2B395
Where it is running
30 locations listed across 8 US states.
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- Banner MD Anderson Cancer Center - Gilbert, Arizona, United States
- UCSD Moores Cancer Center - La Jolla, California, United States
- UCSD Moores Cancer Center - La Jolla, California, United States
- UCSD Moores Cancer Center - La Jolla, California, United States
- UCLA Medical Center - Los Angeles, California, United States
- UCLA Medical Center - Los Angeles, California, United States
- UCLA Medical Center - Los Angeles, California, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Washington University - St Louis, Missouri, United States
- Washington University - St Louis, Missouri, United States
- Washington University - St Louis, Missouri, United States
- NYU Langone Health - New York, New York, United States
- NYU Langone Health - New York, New York, United States
- NYU Langone Health - New York, New York, United States
- The Ohio State University - Columbus, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- Fred Hutch Cancer Center - Seattle, Washington, United States
- Fred Hutch Cancer Center - Seattle, Washington, United States
- Fred Hutch Cancer Center - Seattle, Washington, United States