This is an open label, phase I study to assess the safety and efficacy of CD33 CAR-T in patients with relapsed and refractory acute myeloid leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
CD33 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Evaluation of Safety
Count the Incidence of adverse events
Time frame: Up to 2 years after CD33CAR-T infusion
Changes in cytokine level after CD33 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.
Time frame: Up to 2 years after CD33CAR-T infusion
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time frame: Up to 2 years after CD33CAR-T infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Time frame: Up to 2 years after CD33CAR-T infusion
Overall response Rate(ORR)
Proportion of subjects who achieved CR, CRi, or PR
Time frame: Up to 2 years after CD33CAR-T infusion
He Huang, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.