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

Launched by A2 BIOTHERAPEUTICS INC. · Nov 7, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called A2B395 for patients with certain types of solid tumors, such as colorectal cancer, lung cancer, and triple-negative breast cancer. The main goal is to find out the safest dose of A2B395 and see if it can effectively kill cancer cells while protecting healthy cells. Participants will need to meet specific criteria, such as having a confirmed diagnosis of certain cancers and being able to complete the study procedures.

If someone is eligible and decides to participate, they will receive the A2B395 treatment along with some other preparatory treatments. They’ll also undergo regular check-ups to monitor their health and the treatment's effectiveness. It’s important for potential participants to know that they should not have had certain recent cancer treatments or have specific health conditions that could complicate their participation. Overall, this trial aims to provide more options for patients facing challenging cancers.

Gender

ALL

Eligibility 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