Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Launched by ALLOGENE THERAPEUTICS · Jan 4, 2021

Keywords

ClinConnect Summary

The TRAVERSE study is a clinical trial investigating the safety and effectiveness of a new treatment called ALLO-316 for adults with advanced or metastatic clear cell renal cell carcinoma, which is a type of kidney cancer. This trial is in its early Phase 1 stage, where researchers are trying to find the right dose of the drug and see how well it works after patients have received specific prior treatments. To participate, patients should have a confirmed diagnosis of clear cell renal cell carcinoma, have already received certain types of cancer therapies (specifically a checkpoint inhibitor and a VEGF inhibitor), and have measurable cancer lesions.

Participants in this trial can expect to undergo a treatment regimen that includes lymphodepletion—essentially preparing their body to receive the new therapy—before starting ALLO-316. The trial is currently recruiting patients aged 18 and older. It’s important to note that patients with certain conditions, such as active brain cancer or other significant health issues, may not be eligible. Additionally, participants will be monitored closely for safety during and after the treatment to gather important information for future studies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed renal cell carcinoma with a predominant clear cell component.
• • Must have received a checkpoint inhibitor and a VEGF inhibitor in the advanced and/or metastatic setting.
• • At least one measurable lesion as defined by RECIST version 1.1
• • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
• • Absence of donor (product)-specific anti-HLA antibodies (DSA).
• • Adequate hematological, renal, liver, pulmonary, and cardiac functions.
• Exclusion Criteria:
• • Central nervous system (CNS) metastatic disease (unless controlled and stable for at least 4 weeks), leptomeningeal disease, or cord compression.
• • Clinically significant CNS dysfunction.
• • Any other active malignancy within 3 years prior to enrollment.
• • Prior treatment with anti-CD70 therapies.
• • Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy.
• • Prior treatment with anti-CD52 monoclonal antibody in the past 12 months.
• • Patients unwilling to participate in the extended safety monitoring period.