The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.
This is a single arm, open label and non-randomized clinical study with two parts. In Part 1, 9 subjects with advanced solid tumors will be enrolled into Groups A (no non-myeloablative lymphodepletion), B and C (non-myeloablative lymphodepletion with different chemotherapy intensities) to assess the safety and dose intensity of non-myeloablative lymphodepletion chemotherapy before cell infusion. Depending on results in Part 1, the study may proceed to Part 2, where 15 subjects with advanced solid tumors will be enrolled to receive TSA-CTL cell infusions with or without non-myeloablative lymphodepletion.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Patients will receive TSA-CTL iv over 20-30 minutes on day 0.
Cyclophosphamide 500 mg/m2/day iv on day -5 for one day.
Fludarabine 25 mg/m2/day iv over 30 minutes on day -5 and -4 for two days.
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Number of participants with adverse events as assessed by CTCAE v5.0.
Keep records the adverse events experienced by subjects in 30 days after the first infusion.
Time frame: one month
Disease Control Rate(DCR)
DCR is defined as the proportion of participants with tumor size reduction(CR,PR) and stable disease(SD) assessed by RECIST 1.1 and iRECIST.
Time frame: one year
overall survival(OS)
The time from the first infusion of Investigational Product until death.
Time frame: one year
progression-free survival(PFS)
PFS is defined as the time from the first infusion of Investigational Product until objective tumor progression, as assessed by RECIST 1.1 and iRECIST, or death, whichever occurs first.
Time frame: one year
Duration of Response(DOR)
DOR refers to the period from the first evaluation of tumor as CR or PR to the first evaluation as PD(Progressive Disease) per RECIST1.1 and iRECIST.
Time frame: one year
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Cyclophosphamide 500 mg/m2/day iv on day -5 and -4 for two days.