AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)

Launched by ARSENAL BIOSCIENCES, INC. · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AB-2100, which is a type of cell therapy for patients with advanced or recurrent clear-cell renal cell carcinoma (ccRCC), a form of kidney cancer. The goal is to see how safe and effective this treatment is for patients who have already received other therapies, specifically an immune checkpoint inhibitor and a VEGF-targeted therapy, and have experienced disease progression or unacceptable side effects. The trial is expected to include about 60 participants in the first phase and around 70 in the second phase.

To be eligible, participants should be between the ages of 65 and 74 and must have measurable disease, meaning their cancer can be tracked. They should also have a good performance status, which means they are generally well enough to participate. Participants will need to agree to use contraception for at least a year after receiving the treatment. Throughout the trial, patients can expect close monitoring for their safety and health, as well as regular check-ins regarding their cancer's response to the therapy. It’s important to note that there are certain health conditions and recent treatments that could prevent someone from joining this study, so potential participants should discuss their medical history with the research team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Advanced or metastatic clear-cell renal cell carcinoma
• • Must have received an immune checkpoint inhibitor and a VEGF-targeted therapy in the advanced or metastatic setting. Must have evidence of progression on or after the last treatment regimen or discontinued treatment for unacceptable toxicity.
• • Adequate organ function as per protocol definitions.
• • Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
• • Measurable disease at time of enrollment as per protocol definitions.
• • Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after AB-2100 infusion.
• Exclusion Criteria:
• • Any prior systemic RCC therapy within 14 days of time of cell collection (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent).
• • Systemic anti-cancer therapy within 14 days of starting of conditioning chemotherapy (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent)
• • Investigational cellular therapies within 8 weeks prior to start of conditioning chemotherapy
• • Prior treatment with anti-CA9 therapies
• • Myocardial infarction or unstable angina within 6 months prior to screening
• • Pleural effusion that requires drainage for symptom management within 28 days of screening.
• • Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment.
• • Untreated brain metastasis.
• • Subjects unwilling to participate in an extended safety monitoring period.