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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245018
• Other study ID #: iNK-1002
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: March 1, 2030

Study information

• Verified date: January 2024
• Source: Nuwacell Biotechnologies Co., Ltd.
• Contact: Xiaowen Gong
• Phone: +8615221195602
• Email: xwgong[@]nuwacell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2030
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• iNK Injection
Subjects will receive about 4 cycles of iNK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nuwacell Biotechnologies Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Dose-Limiting Toxicity(DLT)	Number of participants with Dose-limiting toxicity in 28 days after injection	4 weeks after initial infusion
Secondary	Objective Response Rate(ORR)	Percentage of participants achieved Complete Response(CR) or Partial Response(PR)	During the whole study
Secondary	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
Secondary	Duration Of Response(DOR)	Duration for the first PR to the first Progressive Disease(PD)	First Injection to a year after Last Injection