To learn if the VGO-Cs01p can help to control CD7-positive relapsed/refractory acute T-lymphoblastic leukemia (R/R T-ALL) in children.
Age ≥2 and ≤18 years old, male or female;
Subjects who have relapse or refractory T-cell lymphoblastic leukemia (T-ALL) according to the standards of the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2024.V6);
Meets the criteria for recurrent or refractory T-ALL, including: a) Recurrent: Reappearance of blasts in peripheral blood or bone marrow (>25%) after complete remission or occurrence of extramedullary disease, and ineffectiveness of other treatments； b) Primary Refractory: Appearance of blasts in bone marrow ≥5% after 2 months standard induction chemotherapy, and no other treatment can be used as judged by the investigator;
After one cycle of other treatments (such as Olverembatinib combined with APG-125), the blasts remain≥5%;
Extramedullary involvement of the central nervous system or testicular at screening.
Patients with a history of severe CNS diseases, such as uncontrolled seizures, stroke, severe brain damage resulting in speech impairment, psychiatric disorders, etc;
NYHA functional class III or IV heart failure;
Presence of disseminated intravascular coagulation;
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Children's Medical Center
Sponsor institution
Shanghai Vitalgen BioPharma Co., Ltd.
Collaborator