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;
Sequential
VGO-Cs01p
Biological/VaccineOff-the-shelf NK cell products derived from human embryonic stem cells (hESCs)
Incidence and severity of adverse events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product; the event will not need to have a causal relationship with the treatment.
ORR（Objective response rate）
Includes CR (complete response)/ CRh (CR with partial hematological recovery) /CRi (CR with incomplete hematological recovery)/PR（partial response）.
MRD (Minimal/Measurable Residual Diseas)
Minimal/Measurable Residual Disease negative response rate
DOR (Duration of response)
DOR is defined as the time from the first assessment of CR/CRh/CRi to relapse or death in clinical remission.
LFS (Leukemia-Free Survival)
Defined as the time from clinical remission (CR/CRh/CRi) to relapse or death in clinical remission.
Click on the lead sponsor to view all of their trials.
Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Children's Medical Center
Sponsor institution
Shanghai Vitalgen BioPharma Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
