A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
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: NK042, Fludarabine (FLU), Cyclophosphamide (CTX).
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 70 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
- China
- 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-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
Overview
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.
Interventions
- Biological NK042
NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells. - Drug Fludarabine (FLU)
Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion. - Drug Cyclophosphamide (CTX)
Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.
Primary outcome measures
- Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 1 year after first dose of NK042.]
- Dose Limiting Toxicities (DLTs) [Time frame: Up to 28-day after first dose of NK042.]
- Objective Response Rate (ORR) [Time frame: Up to 1 year after first dose of NK042.]
Secondary outcome measures (8)
- Peak plasma concentration (Cmax) [Time frame: 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.]
- Time to reach maximum concentration (Tmax) [Time frame: 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.]
- Area under the plasma concentration versus time curve (AUC₀-ₜ) [Time frame: 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.]
- Half-life (T₁/₂) of NK042 [Time frame: 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.]
- Progression-Free Survival (PFS) [Time frame: Up to 1 year after first dose of NK042 .]
- Overall Survival (OS) [Time frame: Up to 1 year after first dose of NK042 .]
- Duration of Response (DOR) [Time frame: Up to 1 year after first dose of NK042 .]
- Disease Control Rate (DCR) [Time frame: Up to 1 year after first dose of NK042 .]
Eligibility criteria
Inclusion criteria
- Voluntary signing of a written informed consent form.
- Age between 18 and 70 years.
- 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.
- At least one assessable tumor lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Expected survival ≥12 weeks.
- Must have adequate bone marrow, liver, and renal function.
Exclusion criteria
- Insufficient washout period for prior anti-tumor treatments before the first dose, including chemotherapy, targeted therapy, antibody therapy, and radiotherapy.
- Participation in another clinical trial and use of investigational drugs within 28 days before the first dose.
- Requirement for anticoagulation therapy.
- Symptomatic brain parenchymal metastases with less than 4 weeks of stability after treatment.
- Active pulmonary diseases, including but not limited to interstitial lung disease, pneumonitis.
- Uncontrolled active infections.
- Uncontrollable massive pleural effusion, ascites, or pericardial effusion.
- Previous receipt of other cellular therapies.
- Planned concurrent participation in other anti-tumor treatments during the study.
- Pregnant or breastfeeding women.
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
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Cancer Hospital — Beijing
Identifiers
NCT: NCT06773091 · NK042-I-ST-01