A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

Launched by CRISPR THERAPEUTICS AG · Mar 21, 2023

Keywords

ClinConnect Summary

The clinical trial titled "A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors" is exploring a new treatment called CTX131 for adults with certain types of advanced cancer, including clear cell kidney cancer, cervical cancer, esophageal cancer, pancreatic cancer, and malignant pleural mesothelioma. This study is currently recruiting participants who are at least 18 years old and have cancer that cannot be surgically removed or has returned after previous treatments. To qualify, individuals should have a good performance status, meaning they can carry out daily activities with minimal limitations, and they need to have healthy functioning of their kidneys, liver, heart, and lungs.

Participants in this trial will receive CTX131 and will be closely monitored for its safety and effectiveness. They will be asked to use reliable contraception during the study and for at least 12 months after receiving the treatment, especially if they can become pregnant. It's important to note that individuals with certain health conditions, those who have had specific previous treatments, or who are pregnant or breastfeeding are not eligible to participate. This trial aims to provide valuable information about CTX131 and how it may help patients with these challenging cancers.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
• • 3. Eastern Cooperative Oncology Group performance status 0 or 1.
• • 4. Adequate renal, liver, cardiac and pulmonary organ function.
• • 5. 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 CTX131 infusion.
• Key Exclusion Criteria:
• • 1. Prior treatment with anti-CD70 targeting agents
• • 2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
• • 3. Presence of uncontrolled bacterial, viral, or fungal infection.
• • 4. Active HIV, hepatitis B virus or hepatitis C virus infection.
• • 5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
• • 6. Women who are pregnant or breastfeeding.