Evaluating a new CAR T-cell therapy for solid tumors expressing EGFR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and efficacy of A2B395, an allogeneic logic-gated CAR T-cell therapy, in adults with solid tumors such as colorectal cancer and non-small cell lung cancer that express EGFR and have lost HLA-A*02 expression. The study is designed in two phases: Phase 1 focuses on determining the recommended safe dose of A2B395, while Phase 2 assesses its effectiveness in killing tumor cells while protecting healthy cells. Participants will undergo a preconditioning lymphodepletion regimen before receiving the CAR T-cell treatment. The study is multi-center and open-label, involving several prominent cancer treatment centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• UCSD Moores Cancer Center
  La Jolla, California, United States Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: ClinicalTrials@a2bio.com
• Phone: 310-431-9180

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.