Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
Trial Parameters
Brief Summary
To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
Eligibility Criteria
Inclusion Criteria: The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF). Male or female, aged 12 to 65 years at the time of signing the ICF (inclusive of the cutoff values). Expected survival of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of signing the ICF. At the time of signing the ICF, the patient must be diagnosed with R/R B-ALL and meet the following criteria: 1. Bone marrow morphological examination at screening shows \>5% blasts in the bone marrow, and/or cerebrospinal fluid (CSF) analysis detects leukemic cells, and/or the presence of measurable extramedullary lesions, defined as: Any lymph node or mass with an axial diameter \>1.5 cm Any extranodal lesion with an axial diameter \>1.0 cm 2. Flow cytometry confirms CD19 or CD22 positivity in tumor cells from bone marrow, peripheral blood, or cerebrospinal fluid, or pathology confirms C