NK042 cell injection for advanced solid tumors

An Open-Label, Single-Arm, Multicenter Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of NK042 Cell Injection (Universal NKR+NK) in Advanced Solid Tumors

This study is testing a new cell injection called NK042 to see if it can safely help people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai NK Cell Technology Co., LTD (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06773091 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label, multi-center phase 1 clinical study designed to evaluate the safety and preliminary efficacy of NK042 cell injection in patients with advanced solid tumors. The study consists of two phases: Phase Ia, which involves dose-escalation with both single and multiple doses of NK042, and Phase Ib, which focuses on expanding cohorts for solid tumor indications that showed preliminary efficacy in Phase Ia. The study aims to assess how well NK042 can be tolerated and its potential effectiveness in treating these tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed advanced solid tumors that are not amenable to surgical resection and have no standard treatment options available.

Not a fit: Patients who have recently undergone other anti-tumor treatments or are currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited or no standard treatment options.

How similar studies have performed: While this approach is novel, similar studies using CAR-NK cell therapies have shown promise in early-phase trials.

Eligibility criteria

Inclusion Criteria:

1. Voluntary signing of a written informed consent form.
2. Age between 18 and 70 years.
3. Histologically or cytologically confirmed locally advanced or metastatic solid tumor patients who are not amenable to surgical resection, with no standard treatment options, or who have relapsed or progressed after standard treatment, or are resistant or intolerant to standard treatment.
4. At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Expected survival ≥12 weeks.
7. Must have adequate bone marrow, liver, and renal function.

Exclusion Criteria:

1. Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
2. Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
3. Requirement for anticoagulation therapy.
4. Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
5. Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
6. Uncontrolled active infections.
7. Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
8. Previous receipt of other cellular therapies.
9. Planned concurrent participation in other anti-tumor treatments during the study.
10. Pregnant or breastfeeding women.

Where this trial is running

Beijing

• Peking University Cancer Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yongling Fu

Conditions: Advanced Solid Tumors, CAR-NK, Advanced solid tumors, Early-phase clinical trial, Cell Therapy