Advanced Solid TumorsPhase 1NKSOLIDNCT06773091
A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors
A Phase 1 study testing NK042, Fludarabine (FLU) and Cyclophosphamide (CTX) in people with Advanced Solid Tumors, run by Shanghai NK Cell Technology Co., LTD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NK042, Fludarabine (FLU) and Cyclophosphamide (CTX)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, 100142
Changsong QI, MD, +0086010-88196561, xiwangpku@126.com
Lin Shen, MD
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- NK042, Fludarabine (FLU), Cyclophosphamide (CTX)
- Keywords
- CAR-NK, Advanced solid tumors, Early-phase clinical trial, Cell Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK042Biological
NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells.
Fludarabine (FLU)Drug
Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion.
Cyclophosphamide (CTX)Drug
Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion.
| Study group | Role | What they receive |
|---|---|---|
| NK042 - cellular therapy | Experimental | 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. Receives: Biological: NK042; Drug: Fludarabine (FLU); Drug: Cyclophosphamide (CTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: Up to 1 year after first dose of NK042.
Dose Limiting Toxicities (DLTs)
Identification of DLTs to determine the maximum tolerated dose (MTD).
Measured: Up to 28-day after first dose of NK042.
Objective Response Rate (ORR)
The proportion of participants achieving a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
Measured: Up to 1 year after first dose of NK042.
Secondary outcomes (8)
Peak plasma concentration (Cmax)
Cmax of NK042 will be measured to determine the maximum concentration reached in the plasma following administration.
Measured: 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)
Tmax of NK042 will be assessed to determine the time point at which the highest plasma concentration is observed following administration.
Measured: 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)
AUC₀-ₜ will be assessed to determine the total NK042 exposure from the time of administration (0) to the last measurable concentration (t).
Measured: 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
T₁/₂ of NK042 will be assessed to determine the time required for a 50% reduction in the maximum amount of circulating NK042 in the plasma.
Measured: 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)
The time from the first dose until objective tumor progression or death.
Measured: Up to 1 year after first dose of NK042 .
Overall Survival (OS)
The time from the first dose until death from any cause.
Measured: Up to 1 year after first dose of NK042 .
Duration of Response (DOR)
The time from the first documentation of CR or PR to disease progression or death.
Measured: Up to 1 year after first dose of NK042 .
Disease Control Rate (DCR)
The proportion of participants who achieve a CR, PR, or stable disease (SD) as assessed by RECIST 1.1.
Measured: Up to 1 year after first dose of NK042 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start7 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NK Cell Technology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773091
- Sponsor's protocol ID
- NK042-I-ST-01
- Acronym
- NKSOLID
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06773091
- Acronym / sponsor ID
- NKSOLID / NK042-I-ST-01
- Conditions
- Advanced Solid Tumors
- Keywords
- CAR-NK, Advanced solid tumors, Early-phase clinical trial, Cell Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shanghai NK Cell Technology Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK042 - cellular therapy | Experimental | Biological: NK042, Drug: Fludarabine (FLU), Drug: Cyclophosphamide (CTX)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK042NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells. | Biological | NK042 - cellular therapy |
| Fludarabine (FLU)Fludarabine (FLU) is administered as a lymphodepletion regimen prior to NK042 infusion. | Drug | NK042 - cellular therapy |
| Cyclophosphamide (CTX)Cyclophosphamide (CTX) is administered as a lymphodepletion regimen prior to NK042 infusion. | Drug | NK042 - cellular therapy |
Primary outcome
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 1 year after first dose of NK042.
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.
Dose Limiting Toxicities (DLTs)
Time frame: Up to 28-day after first dose of NK042.
Identification of DLTs to determine the maximum tolerated dose (MTD).
Objective Response Rate (ORR)
Time frame: Up to 1 year after first dose of NK042.
The proportion of participants achieving a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).
8 secondary outcomes
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 .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK042, Fludarabine (FLU) and Cyclophosphamide (CTX) in people with Advanced Solid Tumors, run by Shanghai NK Cell Technology Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongling Fu (+0086 02150888199, yongling.fu@nk-celltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 1 year after first dose of NK042.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.