The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
The goal of this clinical trial is to explore the effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are: To evaluate the safety of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\~30 mL normal saline.
Shanxi Bethune Hospital
Taiyuan, Shangxi, China
RECRUITINGOverall response rate
Including complete remission (CR) and partial remission (PR)
Time frame: 6 months
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose
Incidence of DLTs and occurrence of study related adverse events
Time frame: 28 days
Disease-free survival
DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit.
Time frame: 3years
Overall Survival
OS was calculated from the first CAR-T cell infusion to death or last follow-up
Time frame: 3 years
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