This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Subjects will receive about 4 cycles of iNK
Adverse Event(AE) ,Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Time frame: From the date of initial infusion to a year after initial infusion
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days after injection
Time frame: 4 weeks after initial infusion
Objective Response Rate(ORR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR)
Time frame: During the whole study
Disease Control Rate(DCR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD)
Time frame: From the date of initial infusion to a year after initial infusion
Duration Of Response(DOR)
Duration for the first PR to the first Progressive Disease(PD)
Time frame: First Injection to a year after Last Injection
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