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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE) [Срок оценки: From the date of initial infusion to a year after initial infusion]
• Dose-Limiting Toxicity(DLT) [Срок оценки: 4 weeks after initial infusion]

Вторичные конечные точки (3)

• Objective Response Rate（ORR） [Срок оценки: During the whole study]
• Disease Control Rate（DCR） [Срок оценки: From the date of initial infusion to a year after initial infusion]
• Duration Of Response（DOR） [Срок оценки: First Injection to a year after Last Injection]

Критерии участия

Критерии включения

• ≥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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06245018 · iNK-1002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗