A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

Last updated: April 3, 2026
Sponsor: Shanghai NK Cell Technology Co., LTD
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Fludarabine (FLU)

Cyclophosphamide (CTX)

NK042

Clinical Study ID

NCT06773091
NK042-I-ST-01
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tumorpatients who are not amenable to surgical resection, with no standard treatmentoptions, or who have relapsed or progressed after standard treatment, or areresistant or intolerant to standard treatment.

  4. At least one assessable tumor lesion according to Response Evaluation Criteria inSolid 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

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 28days before the first dose.

  3. Requirement for anticoagulation therapy.

  4. Symptomatic brain parenchymal metastases with less than 4 weeks of stability aftertreatment.

  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.

Study Design

Total Participants: 76
Treatment Group(s): 3
Primary Treatment: Fludarabine (FLU)
Phase: 1
Study Start date:
February 07, 2025
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Peking University Cancer Hospital

    Beijing, 100142
    China

    Active - Recruiting

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