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

An Open, Dose Escalation and Extension Platform Trial to Evaluate the Safety, Pharmacological and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Natural Killer Cells (iNK) in Chinese Subjects With Solid Tumor

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

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: iNK Injection

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaowen Gong; Phone Number: +8615221195602; Email: xwgong@nuwacell.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iNK Injection; Cohort1:Low dose iNK injection; Cohort2:Mid dose iNK injection; Cohort3:High dose iNK injection;	Biological: iNK Injection; Subjects will receive about 4 cycles of iNK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Nuwacell Biotechnologies Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2030

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: iNK
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: iNK-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No