To evaluate the safety and efficacy of anti-Siglec-6 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
Sialic acid-binding immunoglobulin-like lectins (Siglec) are a class of classical immunoglobulin-like lectins. Studies have shown that Siglec-6 is commonly expressed in AML but not detected on normal hematopoietic stem and progenitor cells (HSC/P). In vitro experiments revealed that anti-Siglec-6 CAR-T cell treatment did not affect the viability or lineage differentiation in colony-forming assays. These data suggest that anti-SigLlec-6 is an ideal target with great potential for treating acute myeloid leukemia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Enrolled patients will receive prespecified dose of autologous CAR-T cells.
Kailin Xu
Xuzhou, Jiangsu, China
RECRUITINGDose-limiting toxicity(DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after T cell infusion
MRD negative overall response rate (MRD- ORR)
Assessment of MRD negative overall response rate (MRD- ORR) at 3 months of treatment
Time frame: 3 months
Overall response rate (ORR)
Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24
Time frame: Month 6, 12, 18 and 24
Event-free survival (EFS)
Assessment of EFS at Month 6, 12, 18 and 24
Time frame: Month 6, 12, 18 and 24
Overall survival (OS)
Assessment of OS at Month 6, 12, 18 and 24
Time frame: Time Frame: Month 6, 12, 18 and 24
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