Clinical trial · Interventional
A Phase I Study of NK042 Cell Injection in 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
NCT06773091CI-TRIAL-00107314NKSOLIDrecruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide (CTX) | Drug | Cyclophosphamide | ALIAS |
| Fludarabine (FLU) | Drug | Fludarabine | ALIAS |
| NK042 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK042 - cellular therapy
- description
- Phase Ia (Dose Escalation): Determines maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) using single- and multiple-dose escalation with a "3+3" design. Phase Ib (Cohort Expansion): Evaluates safety, tolerability, and efficacy in solid tumor indications that demonstrated preliminary efficacy in Phase Ia. Participants undergo lymphodepletion prior to the first infusion of NK042.
- interventionNames
- Biological: NK042
- Drug: Fludarabine (FLU)
- Drug: Cyclophosphamide (CTX)
Primary outcomes (3)
- measure
- Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Up to 1 year after first dose of NK042.
- description
- Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),version 5.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.