About this trial
This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old.
Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
Have 1 or more focus can be accessed according to RECIST 1.1
Disqualifiers
Central nervous system metastasis or meningeal metastasis with clinical symptoms;
With active infection during screening
Have serious or uncontrolled basic diseases;
Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety;
Trial design
Sequential
Treatments tested in this trial
iNK Injection
Biological/VaccineSubjects will receive about 4 cycles of iNK
Treatment groups
Trial outcomes
Primary outcomes
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
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days after injection
Secondary outcomes
Objective Response Rate(ORR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR)
Disease Control Rate(DCR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD)
Duration Of Response(DOR)
Duration for the first PR to the first Progressive Disease(PD)
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: