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.
Age ≥18 years, no restriction on sex.
ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2.
Expected survival ≥3 months.
For relapsed/refractory B-NHL: at least one measurable lesion as assessed by the investigator (e.g., lymph node with long axis >15 mm, or extranodal lesion with long axis >10 mm).
Patients with CNS involvement of B-cell malignancies confirmed by lumbar puncture and/or MRI with CNS-related symptoms.
Patients with isolated extramedullary relapse of B-ALL.
Patients with severe hereditary diseases or congenital hematopoietic dysfunction.
Patients with Burkitt's lymphoma/leukemia or blast phase chronic myeloid leukemia (p210 BCR-ABL+).