Safety and Efficacy of ZZSW-01 in Relapsed/Refractory B-cell Malignancies
Trial Parameters
Brief Summary
This is a single-center, single-arm, open-label, dose-escalation, early-phase 1 study to evaluate the safety, tolerability and preliminary efficacy of ZZSW-01 injection in patients with relapsed/refractory B-cell malignancies.
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following inclusion criteria: 1. Age ≥18 years, no restriction on sex. 2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2. 3. Expected survival ≥3 months. 4. Histologically or cytologically confirmed CD19-positive relapsed or refractory B-cell malignancies according to the WHO classification of lymphoid neoplasms, including: Relapsed/refractory B-NHL: patients who have failed at least two prior lines of therapy, are intolerant to the toxicity of second-line regimens, or are not eligible for autologous stem cell transplantation, including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL/high-grade B-cell lymphoma with MYC and BCL2 rearrangements, high-grade B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, mantle cell lymphoma, grade 3b follicular lymphoma, and transformed large B-cell lymphoma from indolent B-NHL. Relapsed/refractory precurs