A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor

Nuwacell Biotechnologies

Status: Not yet enrolling

Conditions: Solid Tumor

Treatments: Biological: iNK Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06245018

iNK-1002

Details and patient eligibility

About

This trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

iNK Injection

Experimental group

Description:

Cohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection;

Treatment:

Biological: iNK Injection