Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Tao LIU, PHD
CONTACT
Lead
Shenzhen Fifth People's Hospital
Single Site, single arm and open label design are adopted. The dose increment is based on the traditional "3 + 3" method, and the initial dose is set to 0.5 × 10\^6 car-t cells / kg, and 3 \~ 6 subjects are expected to be included in each dose group. DLT was observed within 28 days after infusion. One suject of each dose group was enrolled first, and there was no DLT within 14 days before entering the next subject. If the subject had DLT within 14 days, the investigator can evaluate whether the dose group continued to be enrolled and the time interval of the next subject. After completing the safety observation of 3 subjects who meet the DLT evaluation and analysis set in each dose group, they can be increased to the next dose when there is no DLT; If one subject in the first three cases has DLT, another three subjects need to be selected into the dose group (but the researcher can also decide whether to continue to be selected into the dose group according to the actual situation of the subjects). In the process of dose increase, if DLT occurs in ≥ 2 / 3 or ≥ 2 / 6 subjects in a dose group, the dose increase stops.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
