A Study to Evaluate the Safety and Efficacy of A2B694, a Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Launched by A2 BIOTHERAPEUTICS INC. · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called A2B694 for patients with certain types of solid tumors, like colorectal cancer, pancreatic cancer, and lung cancer. The goal is to see if A2B694 can safely kill tumor cells while protecting healthy cells. This trial is divided into two phases: the first phase will determine the safest dose of A2B694, and the second phase will assess how effective this treatment is in fighting the cancer.

To be eligible for this trial, participants should have been diagnosed with specific types of solid tumors that have certain characteristics, such as expressing a protein called MSLN and having lost a specific marker called HLA-A*02. They also need to have measurable disease and meet other health criteria. Those who join the study will undergo some procedures, including a special treatment to prepare their bodies, before receiving the A2B694 treatment. It’s important for participants to be willing to follow the study schedule and attend follow-up appointments to monitor their health over time.

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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), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy
• • 2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, OVCA, MESO, or other solid tumors with MSLN 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. MESO with pleural involvement extending into the peritoneum
• • 5. Cancer therapy within 3 weeks or 3 half lives of A2B694 infusion
• • 6. Radiotherapy within 28 days of A2B694 infusion
• • 7. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
• • 8. 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
• • 9. 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
• • 10. Requires supplemental home oxygen
• • 11. Females of childbearing potential who are pregnant or breastfeeding
• • 12. 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 A2B694