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

NCT06245018 | Not Yet Recruiting

• 1 other identifier: iNK-1002
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Keywords

iNK

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Objective Response Rate（ORR）

  During the whole study

• Disease Control Rate（DCR）

  From the date of initial infusion to a year after initial infusion

• Duration Of Response（DOR）

  First Injection to a year after Last Injection

Study Arms (1)

iNK Injection

EXPERIMENTAL

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

Biological: iNK Injection

Interventions

iNK Injection BIOLOGICAL

Subjects will receive about 4 cycles of iNK

iNK Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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；
• Accept anti-tumor therapy within 28 days before first injection;
• Accept general anesthesia surgery or radiation therapy within 28 days before first injection;
• Accept live vaccine or attenuated live vaccine within 28 days before first injection;
• Allergy to known drug components;
• Serous cavity effusion requiring clinical intervention；
• Pregnancy or prepare to pregnant during the treatment;
• Other situations that not suitable to participate into this trial.

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead

MeSH Terms

Interventions

Ink

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Xiaowen Gong

CONTACT

+8615221195602; xwgong@nuwacell.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 7, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share