This study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (M4/M5).
Our group has developed a novel anti-ILT3 CAR T cell therapy, and this pilot study is focused on the safety and efficacy of the anti-ILT3 CAR-T for R/R AML(M4/M5) patients. A total of 25 subjects are intravenously adminstered with anti-ILT3 CAR-T cells. The dosages of CAR-T cells follow the "3+3" dose increment program.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Autologous T cells genetically modified with anti-ILT3 CAR
Zhejiang Provincal People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGRate of grade 3 or 4 treatment related adverse effects
All the CAR-T treatment related adverse events,including Dose limiting toxicity (DLT), cytokine release syndrome (CRS), CAR-T associated encephalopathy syndrome, will be assessed and graded by NCI CTCAE v 5.0.
Time frame: up to 24 weeks after first infusion
Implantation endpoint
To assess the duration of CAR-positive T cells in circulation, the copy number of CAR DNA was measured at the preset follow-up time point. The time when the results of any two consecutive tests were negative, were recorded as the "implantation endpoint"
Time frame: up to 2 years after first infusion
Disease specific response
Disease specific response includes, but are not limited to, complete response (CR) including morphological leukemia-free status, morphological CR, cytogenetic CR, molecular CR, and partial response (PR).
Time frame: up to 2 years after first infusion
Overall survival
From date of inclusion to date of progression, relapse, or death from any cause
Time frame: up to 2 years after inclusion
Progress-free survival
The length of time that a participant's disease did not progress during and after CAR-T treatment
Time frame: up to 2 years after inclusion
CAR-T residue
The residue of CAR-positive T cells in circulation determined by flow cytometry
Time frame: up to 2 years after first infusion
Minimal residual disease (MRD)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MRD is a status that none tumor cells can be detected by standard cell morphology.
Time frame: up to 2 years after first infusion