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Not yet recruiting NCT06245018

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

No phase Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iNK Injection.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE) [Time frame: From the date of initial infusion to a year after initial infusion]
  • Dose-Limiting Toxicity(DLT) [Time frame: 4 weeks after initial infusion]
Secondary outcome measures (3)
  • Objective Response Rate（ORR） [Time frame: During the whole study]
  • Disease Control Rate（DCR） [Time frame: From the date of initial infusion to a year after initial infusion]
  • Duration Of Response（DOR） [Time frame: First Injection to a year after Last Injection]

Eligibility criteria

Inclusion criteria

  • ≥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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06245018 · iNK-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗