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

Not Applicable

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Biological: iNK Injection

• Registration Number: NCT06245018
• Lead Sponsor: Nuwacell Biotechnologies Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study Start: 2024-02-01
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2027-03-01
• Study Completion: 2030-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
iNK Injection	iNK Injection	Cohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection;

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)