Solid Tumor
Conditions
Keywords
iNK
Brief summary
This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.
Detailed description
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.
Interventions
BIOLOGICALiNK Injection
Subjects will receive about 4 cycles of iNK
Sponsors
Nuwacell Biotechnologies Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old. 2. Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy; 3. Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment. 4. Have 1 or more focus can be accessed according to RECIST 1.1 5. Eastern Cooperative Oncology Group(ECOG):0-1 6. Expected survival period over 3 months 7. 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 8. Agree to contraception 9. Subjects who understand and voluntarily sign the Informed Consent Form（ICF)
Exclusion criteria
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms； 2. With active infection during screening 3. Have serious or uncontrolled basic diseases; 4. Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety； 5. Accept anti-tumor therapy within 28 days before first injection; 6. Accept general anesthesia surgery or radiation therapy within 28 days before first injection; 7. Accept live vaccine or attenuated live vaccine within 28 days before first injection; 8. Allergy to known drug components; 9. Serous cavity effusion requiring clinical intervention； 10. Pregnancy or prepare to pregnant during the treatment; 11. Other situations that not suitable to participate into this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE) | From the date of initial infusion to a year after initial infusion | Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 |
| Dose-Limiting Toxicity(DLT) | 4 weeks after initial infusion | Number of participants with Dose-limiting toxicity in 28 days after injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate（ORR） | During the whole study | Percentage of participants achieved Complete Response(CR) or Partial Response(PR) |
| Disease Control Rate（DCR） | From the date of initial infusion to a year after initial infusion | Percentage of participants achieved Complete Response(CR) or Partial Response(PR) or Stable Disease(SD) |
| Duration Of Response（DOR） | First Injection to a year after Last Injection | Duration for the first PR to the first Progressive Disease(PD) |
Contacts
Primary ContactXiaowen Gong
Outcome results
None listed