A Phase 1/2, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Relapsed or Refractory B-Cell Malignancies

What this Trial Is About

Researchers are evaluating CTX112, an allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy, in adults with relapsed or refractory B-cell malignancies. This open-label, multicenter Phase 1/2 study aims to assess the safety and effectiveness of CTX112, which uses genetically modified T cells edited with CRISPR-Cas9 technology to target cancer cells. The study is sponsored by CRISPR Therapeutics AG and includes patients with various B-cell cancers such as lymphoma and leukemia. Participants receive CTX112 through an intravenous infusion after undergoing lymphodepleting chemotherapy to prepare their bodies. The Phase 1 portion focuses on dose escalation to evaluate safety and identify dose-limiting toxicities within 28 days after infusion. In Phase 2, the study expands to assess objective response rates over up to 60 months. The treatment involves only the CTX112 product administered by IV infusion. During the study, participants will be closely monitored for adverse events, treatment response, and disease progression through clinical assessments and laboratory tests. Researchers will measure outcomes such as duration of response, progression-free survival, and overall survival for up to five years following infusion. Female participants of childbearing potential and male participants must use contraception during the study and for one year afterward. The study excludes those with certain infections, prior transplants, CNS involvement, and other specific medical conditions to ensure participant safety.

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