A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

Launched by CRISPR THERAPEUTICS AG · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called CTX112™ for patients with certain types of B-cell malignancies, which are cancers that affect a specific type of white blood cell. The trial aims to find out if CTX112™ is safe and effective for people whose cancer has come back or has not responded to previous treatments. It is currently looking for participants aged 18 and older who have been diagnosed with these types of cancers, such as B-cell lymphoma or chronic lymphocytic leukemia.

To join the study, participants must have a good general health status and certain organ functions, as well as agree to use contraception during and after the treatment period. This trial will be conducted at multiple sites, meaning it will involve several locations, and participants will be monitored closely for their safety and response to the treatment. If you or a loved one is considering participating, it’s important to discuss it with a healthcare provider to understand all the details and whether it’s a good fit.

Gender

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Eligibility criteria

• Key Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. Refractory or relapsed B cell malignancy.
• • 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 CTX112 infusion.
• Key Exclusion Criteria:
• • 1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
• • 2. Active or history of central nervous system (CNS) involvement by malignancy.
• • 3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
• • 4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
• • 5. Active HIV, hepatitis B virus or hepatitis C virus infection.
• • 6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
• • 7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
• • 8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
• • 9. Women who are pregnant or breastfeeding.

Trial Officials