Clinical trial NCT06245018: A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Tumor
Keywords: iNK
Lead sponsor: Nuwacell Biotechnologies Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Event(AE) ，Serious Adverse Event(SAE)，Treatment Emergent Adverse Event（TEAE）and Treatment Related Adverse Event(TRAE)
timeFrame: From the date of initial infusion to a year after initial infusion
measure: Dose-Limiting Toxicity(DLT)
timeFrame: 4 weeks after initial infusion
Secondary outcomes:
measure: Objective Response Rate（ORR）
timeFrame: During the whole study
measure: Disease Control Rate（DCR）
timeFrame: From the date of initial infusion to a year after initial infusion
measure: Duration Of Response（DOR）
timeFrame: First Injection to a year after Last Injection
Other outcomes:
Locations:
Study officials:
References: