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+).
Single group
ZZSW-01 injection
DrugZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.
Incidence of Adverse Events
All adverse events (AEs), including severe adverse events (SAEs) and clinically significant laboratory abnormalities, will be recorded and graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Incidence of Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) will be specifically identified, recorded, and monitored during the designated DLT observation period.
Incidence and Severity of Cytokine Release Syndrome (CRS)
Cytokine release syndrome (CRS) events will be identified and graded for severity according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Immune effector cell-associated neurotoxicity syndrome (ICANS) will be assessed using the Immune Effector Cell-Associated Encephalopathy (ICE) score and subsequently graded for severity according to the ASTCT consensus grading.
Complete Response (CR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria, including complete response (CR).
Partial Response (PR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Partial Response (PR) rate will be determined.
Stable Disease (SD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Stable Disease (SD) rate will be determined.
Progressive Disease (PD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
Tumor response after ZZSW-01 infusion will be assessed according to the Lugano 2014 criteria or the 2017 ELN criteria. The Progressive Disease (PD) rate will be determined.
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