This is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed/refractory CD19-positive acute lymphoblastic leukemia.
Patients voluntarily sign the informed consent form;
Age between 18 and 65 years, regardless of gender;
(1) Relapse: Relapse within 12 months after first remission following standard treatment;
No remission after ≥6 weeks of induction therapy or two courses of induction therapy;
Active central nervous system (CNS) leukemia (patients with CNS disease symptoms must undergo lumbar puncture to exclude CNS leukemia);
Isolated extramedullary relapse;
Prior CAR-T therapy or other genetically modified cell therapy within 6 months before screening;
Pre-treatment chemotherapy as specified in the protocol;