NCT06773091 A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
| NCT ID | NCT06773091 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai NK Cell Technology Co., LTD |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2025-02-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06773091 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06773091 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06773091 currently recruiting?
Yes, NCT06773091 is actively recruiting participants. Contact the research team at yongling.fu@nk-celltech.com for enrollment information.
Where is the NCT06773091 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06773091 clinical trial?
NCT06773091 is sponsored by Shanghai NK Cell Technology Co., LTD. The trial plans to enroll 76 participants.