Clinical trial NCT06773091: A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: CAR-NK
Advanced solid tumors
Early-phase clinical trial
Cell Therapy
Lead sponsor: Shanghai NK Cell Technology Co., LTD
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is divided into two phases: Phase Ia and Phase Ib.

Dose-Escalation and Expansion:

* Phase Ia: This dose-escalation phase involves both single-dose and multiple-dose administrations of NK042 in patients with advanced solid tumors.
* Phase Ib: This multiple-dose cohort-expansion phase will focus on solid tumor indications that demonstrated preliminary efficacy in Phase Ia.

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.

Primary outcomes:
measure: Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 1 year after first dose of NK042.
measure: Dose Limiting Toxicities (DLTs)
timeFrame: Up to 28-day after first dose of NK042.
measure: Objective Response Rate (ORR)
timeFrame: Up to 1 year after first dose of NK042.
Secondary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: Predose, 4, 24, 48, 72, Day 8, Day 15, Day 22, Day 29 post-dose and every 2 months during the treatment follow-up period.
measure: Time to reach maximum concentration (Tmax)
timeFrame: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.
measure: Area under the plasma concentration versus time curve (AUC₀-ₜ)
timeFrame: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.
measure: Half-life (T₁/₂) of NK042
timeFrame: Predose, 4, 24, 48, 72 hours, Day 8, Day 15, Day 22, Day 29 post-dose, and every 2 months during the treatment follow-up period.
measure: Progression-Free Survival (PFS)
timeFrame: Up to 1 year after first dose of NK042 .
measure: Overall Survival (OS)
timeFrame: Up to 1 year after first dose of NK042 .
measure: Duration of Response (DOR)
timeFrame: Up to 1 year after first dose of NK042 .
measure: Disease Control Rate (DCR)
timeFrame: Up to 1 year after first dose of NK042 .
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: