Evaluating a new CAR T-cell therapy for solid tumors expressing EGFR
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
This study is testing a new CAR T-cell therapy to see if it can safely help adults with certain solid tumors, like colorectal and lung cancer, that have specific markers.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | A2 Biotherapeutics Inc. Industry-sponsored |
| Drugs / interventions | radiation, CAR T |
| Locations | 10 sites (Gilbert, Arizona and 9 other locations) |
| Trial ID | NCT06682793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with recurrent unresectable or metastatic solid tumors that express EGFR and have lost HLA-A*02 expression.
Not a fit: Patients with solid tumors that are suitable for local therapy or who can receive curative standard of care treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, effective treatment option for patients with difficult-to-treat solid tumors.
How similar studies have performed: While CAR T-cell therapies have shown success in hematological malignancies, this approach for solid tumors is still novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gilbert, Arizona and 9 other locations
- 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)
- Washington University — St Louis, Missouri, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Fred Hutch Cancer Center — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials
- Email: ClinicalTrials@a2bio.com
- Phone: 310-431-9180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.