New cell therapy for advanced kidney cancer
An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-2100 in Patients With Recurrent Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC)
PHASE1; PHASE2 · Arsenal Biosciences, Inc. · NCT06245915
This study is testing a new cell therapy for advanced kidney cancer to see if it can help patients who haven't responded to other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Arsenal Biosciences, Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Duarte, California and 8 other locations) |
| Trial ID | NCT06245915 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of AB-2100, an Integrated Circuit T cell therapy, in patients with recurrent clear-cell renal cell carcinoma (ccRCC) who have not responded to previous treatments. The study involves a multi-center approach, enrolling approximately 130 patients across two phases. Participants will receive genetically modified T cells that target specific proteins found on tumor cells, following a conditioning chemotherapy regimen. The primary goal is to determine the maximum tolerated dose of the therapy and its potential effectiveness in fighting cancer.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced or metastatic clear-cell renal cell carcinoma who have previously received immune checkpoint inhibitors and VEGF-targeted therapies.
Not a fit: Patients who have not received prior systemic RCC therapy or those with recent systemic anti-cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced kidney cancer who have limited alternatives.
How similar studies have performed: While this approach is innovative, similar studies using genetically modified T cells have shown promise in other cancers, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Duarte, California and 8 other locations
- City of Hope — Duarte, California, United States (RECRUITING)
- Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
- University of Iowa and Holden Comprehensive Cancer Center — Iowa City, Iowa, United States (RECRUITING)
- Dana Farber Cancer Institue — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
- Memorial Sloan Kettering Cancer Center — New York City, New York, United States (RECRUITING)
- Perlmutter Cancer Center - NYU Langone Health — New York, New York, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Huntsman Cancer Institute - Univ of Utah Health — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Study coordinator: Arsenal Biosciences
- Email: clinicaltrials@arsenalbio.com
- Phone: 650-446-4874
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.
Conditions: Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence, kidney cancer