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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNK Injection | Experimental | Cohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNK Injection | Biological | Subjects will receive about 4 cycles of iNK |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 4 weeks after initial infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Percentage of participants achieved Complete Response(CR) or Partial Response(PR) | During the whole study |
| Disease Control Rate(DCR) | Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD) |
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Inclusion Criteria:
≥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
Eastern Cooperative Oncology Group(ECOG):0-1
Expected survival period over 3 months
Have acceptable organ function and the results of laboratory examination meet the request below:
Hepatic Insufficiency (ALT) and Aspartate aminotransferase(AST)≤3xULN(upper limit of normal);Total Bilirubin≤3xULN;Creatinine≤3xULN;White blood cell count ≥3.0x10^9/L; Absolute Neutrophil Count≥1.0x10^9/L
Agree to contraception
Subjects who understand and voluntarily sign the Informed Consent Form(ICF)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Gong | Contact | +8615221195602 | xwgong@nuwacell.com |
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| ID | Term |
|---|---|
| D007281 | Ink |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| 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) | First Injection to a year after Last Injection |