Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
This study tests a new treatment called C402-CD19-CAR for patients with diffuse large B-cell lymphoma that has stopped responding to previous treatments. The research will measure how safe this treatment is and what dose works best for future studies.
Key Objective: This trial is testing whether C402-CD19-CAR can be safely given to patients whose lymphoma has not responded to standard treatments.
Who to Consider: Patients with relapsed or refractory diffuse large B-cell lymphoma who have exhausted standard treatment options should consider enrolling.
Trial Parameters
Brief Summary
This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.
Eligibility Criteria
Inclusion Criteria: Must meet all the following inclusion criteria: 1. Male or female 18-75 years (inclusive); 2. Patients can understand this study and capable of providing informed consent; 3. Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements; 4. Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), grade 3b follicular lymphoma (FL), transformed diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBL), high-grade B-cell lymphoma (HGBL) with MYC, BCL-2, and/or BCL-6 rearrangements, and high-grade B-cell lymphoma not otherwise specified (HGBL-NOS). For CD19 expression status, subjects with a clear past record of tumor histological diagnosis as CD19-positive (within 6 months prior to screening with no CD19-related treatment in the last 6 months) and tumor