Advanced Solid TumorsPhase 1NCT07784777
NK Cell Injection for Advanced Solid Tumors
A Phase 1 study testing NK CELLS in people with Advanced Solid Tumors, run by BOE Technology Group Co., Ltd..
Trial summary
This is an open-label, single-arm, dose-escalation Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of NK Cell Injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- NK CELLS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years (inclusive), regardless of sex;
- Histologically or cytologically confirmed advanced solid tumor;
- Failed standard treatment, or no standard treatment available, or standard treatment not currently applicable;
- At least one measurable lesion per RECIST 1.1 (non-lymph node lesion >= 1.0 cm in long diameter, or lymph node lesion >= 1.5 cm in short diameter); lesions previously treated with local therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence of definitive progression;
- Adequate bone marrow and organ function:
- ANC >= 1.5 x 10^9/L;
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- Platelet count > 100 x 10^9/L;
- Hemoglobin >= 9 g/dL;
- Total bilirubin < 1.5 x ULN; ALT and AST < 3 x ULN (for liver metastases or primary hepatocellular carcinoma: total bilirubin < 2.5 x ULN, ALT and AST < 5 x ULN);
- Serum creatinine <= 1.5 x ULN;
- PT, APTT, INR < 1.5 x ULN;
- ECOG performance status 0-1;
- Expected survival >= 3 months;
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to cell infusion, and must agree to use reliable contraception during the study and for 6 months after cell infusion; male participants with partners of childbearing potential must agree to use reliable contraception during the study and for 6 months after cell infusion;
- Willing to participate voluntarily and sign the informed consent form (ICF), and able to comply with follow-up requirements.
Who cannot join
- Other malignancies within 5 years prior to screening (except completely resolved carcinoma in situ and malignancies judged by the investigator to be slow-progressing);
- History of leptomeningeal metastasis or CNS metastasis, or definite CNS underlying disease with significant residual symptoms within 6 months prior to cell infusion (asymptomatic brain metastasis or stable symptoms after treatment without corticosteroid use may be allowed);
- Clinically symptomatic moderate to severe third-space effusion requiring therapeutic drainage (except for minimal effusion on imaging without clinical symptoms);
- Severe cardiovascular disease history, including but not limited to: severe arrhythmia or conduction abnormalities requiring clinical intervention; QTcF > 450 ms (male) or > 470 ms (female); acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other >= Grade 3 cardiovascular events within 6 months prior to screening; NYHA functional classification >= II or LVEF < 50%; uncontrolled hypertension (SBP >= 160 mmHg and/or DBP >= 100 mmHg);
- Any active infection (viral, bacterial, fungal) currently under treatment, or any infection requiring >= 7 days of IV antibiotics within the past 6 weeks, or any active infection requiring oral antibiotics within the past 1 week;
- Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppressive therapy;
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- Allergy to lymphodepleting chemotherapy (cyclophosphamide, fludarabine) and/or any component of the study product;
- Prior treatment with other cell therapy products (e.g., DC, CIK, T cells, NK cells, CAR-T, etc.) other than the study product;
- Received other anti-tumor treatment (chemotherapy, targeted therapy, immunotherapy, interventional therapy, or Chinese patent medicine with anti-tumor indications) within 4 weeks prior to infusion;
- Participated in other clinical trials within 3 months prior to infusion;
- Toxicity or complications from prior intervention or treatment not resolved to Grade 2 or below (except alopecia and <= Grade 2 peripheral sensory neuropathy);
- Untreated chronic active hepatitis B, or chronic HBV carrier with HBV DNA >= 1000 copies/mL; HCV antibody positive and HCV-RNA positive; HIV antibody positive; Treponema pallidum antibody positive;
- Other severe organic diseases or psychiatric disorders;
- Pregnant or lactating women;
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of NK Cell Injection in the Treatment of Advanced Solid Tumors
This is an open-label, single-arm, dose-escalation Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of NK Cell Injection in patients with advanced solid tumors.
Eligible participants who have signed written informed consent will be screened and, if qualified, assigned a enrollment number and sequentially assigned to the designated dose group.
Read more
The study employs a traditional "3+3" dose-escalation design. Each dose group enrolls at least 3 participants, with each participant receiving only one corresponding dose level, until the MTD or RP2D is determined.
The study consists of four periods: Screening Period, Treatment Period (including lymphodepleting chemotherapy), Safety Follow-up Period, and Survival Follow-up Period.
- Conditions
- Advanced Solid Tumors
- Being tested
- NK CELLS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK CELLSBiological
Allogeneic natural killer (NK) cell therapy (non-genetically modified)
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation Phase I clinical study | Experimental | Group 1: 2 x 10^9 cells/dose Group 2: 4 x 10^9 cells/dose Group 3: 8 x 10^9 cells/dose
Optional higher dose group: 1 x 10^10 cells/dose (if safety is well-tolerated within the 2-8 x 10^9 cells/dose range, upon SRC assessment after completion of the 8 x 10^9 cells/dose DLT observation period).
Each dose group must include at least 1 female participant. Receives: Biological: NK CELLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Incidence of DLT assessed during the single-infusion DLT observation period (14 days post single infusion) and the multiple-infusion DLT observation period (first cycle, 21 days). DLT is defined per the protocol-specified DLT criteria.
Measured: Up to 21 days post first infusion
Maximum tolerated dose (MTD) and recommended Phase II dose (RP2D)
MTD defined as the highest dose level at which ≤33% of DLT-evaluable participants experience DLT, per protocol-specified dose-escalation rules. RP2D determined based on safety, PK, and preliminary activity across completed dose levels.
Measured: Estimated up to 24 months from first enrollment
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
All-cause AEs and SAEs, including clinically significant laboratory abnormalities, graded per NCI-CTCAE v6.0. Severity classified by CTCAE grade; relationship to study treatment assessed by investigator.
Measured: From first infusion through end of safety follow-up (approximately 30 days after last infusion)
Secondary outcomes (8)
Objective Response Rate
Proportion of participants with complete response (CR) or partial response (PR) as best overall response per RECIST 1.1. Responses confirmed by repeat imaging ≥ 4 weeks after first documentation.
Measured: Every 6 weeks thereafter up to 24 months.
Progression-Free Survival (PFS)
Time from first dose to date of first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.
Measured: From date of first dose until the date of first documented progression or death from any cause, whichever occurs first, assessed up to approximately 24 months
Duration of Response
Time from first documented CR or PR until the date of first documented progression or death from any cause, whichever occurs first, among responders.
Measured: From date of first documented response until the date of first documented progression or death, assessed up to approximately 24 months.
Disease Control Rate
Proportion of participants with CR, PR, or stable disease (SD) lasting ≥ 8 weeks per RECIST 1.1.
Measured: every 6 weeks thereafter up to 24 months
Overall Survival (OS)
Time from first dose to date of death from any cause.
Measured: From date of first dose until the date of death from any cause, assessed up to approximately 2 years.
Quality of Life- EORTC QLQ-C30 Global Health Status and Functional Scales
Mean change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life and functional subscale scores. Scores range from 0 to 100, with higher scores indicating better health-related quality of life and functioning.
Measured: every 6 weeks thereafter,up to approximately 24 months.
Change in Lymphocyte Subsets and Soluble Immune Mediators
Dynamic changes from baseline in peripheral blood lymphocyte subsets
Measured: At baseline (C0D1; pre-dose) through end of treatment,up to approximately 24 months.
Quality of Life - EQ-5D-5L Utility Index and Visual Analog Scale
Mean change from baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) utility index and Visual Analog Scale (VAS) scores. Utility index scores range from -0.391 to 1.000 (China value set), with higher scores indicating better health-related quality of life. VAS scores range from 0 to 100, with higher scores indicating better perceived health.
Measured: every 6 weeks thereafter, up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BOE Technology Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784777
- Sponsor's protocol ID
- JDFZS-08-101
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of NK Cell Injection in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07784777
- Acronym / sponsor ID
- JDFZS-08-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- BOE Technology Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Aug 2026 (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 an open-label, single-arm, dose-escalation Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of NK Cell Injection in patients with advanced solid tumors.
Eligible participants who have signed written informed consent will be screened and, if qualified, assigned a enrollment number and sequentially assigned to the designated dose group.
The study employs a traditional "3+3" dose-escalation design. Each dose group enrolls at least 3 participants, with each participant receiving only one corresponding dose level, until the MTD or RP2D is determined.
The study consists of four periods: Screening Period, Treatment Period (including lymphodepleting chemotherapy), Safety Follow-up Period, and Survival Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation Phase I clinical study | Experimental | Biological: NK CELLSGroup 1: 2 x 10^9 cells/dose Group 2: 4 x 10^9 cells/dose Group 3: 8 x 10^9 cells/dose Optional higher dose group: 1 x 10^10 cells/dose (if safety is well-tolerated within the 2-8 x 10^9 cells/dose range, upon SRC assessment after completion of the 8 x 10^9 cells/dose DLT observation period). Each dose group must include at least 1 female participant. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 to 75 years (inclusive), regardless of sex;
- Histologically or cytologically confirmed advanced solid tumor;
- Failed standard treatment, or no standard treatment available, or standard treatment not currently applicable;
- At least one measurable lesion per RECIST 1.1 (non-lymph node lesion >= 1.0 cm in long diameter, or lymph node lesion >= 1.5 cm in short diameter); lesions previously treated with local therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence of definitive progression;
- Adequate bone marrow and organ function:
Key exclusion criteria (15 listed)
- Other malignancies within 5 years prior to screening (except completely resolved carcinoma in situ and malignancies judged by the investigator to be slow-progressing);
- History of leptomeningeal metastasis or CNS metastasis, or definite CNS underlying disease with significant residual symptoms within 6 months prior to cell infusion (asymptomatic brain metastasis or stable symptoms after treatment without corticosteroid use may be allowed);
- Clinically symptomatic moderate to severe third-space effusion requiring therapeutic drainage (except for minimal effusion on imaging without clinical symptoms);
- Severe cardiovascular disease history, including but not limited to: severe arrhythmia or conduction abnormalities requiring clinical intervention; QTcF > 450 ms (male) or > 470 ms (female); acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other >= Grade 3 cardiovascular events within 6 months prior to screening; NYHA functional classification >= II or LVEF < 50%; uncontrolled hypertension (SBP >= 160 mmHg and/or DBP >= 100 mmHg);
- Any active infection (viral, bacterial, fungal) currently under treatment, or any infection requiring >= 7 days of IV antibiotics within the past 6 weeks, or any active infection requiring oral antibiotics within the past 1 week;
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 |
|---|---|---|
| NK CELLSAllogeneic natural killer (NK) cell therapy (non-genetically modified) | Biological | Dose-escalation Phase I clinical study |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 21 days post first infusion
Incidence of DLT assessed during the single-infusion DLT observation period (14 days post single infusion) and the multiple-infusion DLT observation period (first cycle, 21 days). DLT is defined per the protocol-specified DLT criteria.
Maximum tolerated dose (MTD) and recommended Phase II dose (RP2D)
Time frame: Estimated up to 24 months from first enrollment
MTD defined as the highest dose level at which ≤33% of DLT-evaluable participants experience DLT, per protocol-specified dose-escalation rules. RP2D determined based on safety, PK, and preliminary activity across completed dose levels.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first infusion through end of safety follow-up (approximately 30 days after last infusion)
All-cause AEs and SAEs, including clinically significant laboratory abnormalities, graded per NCI-CTCAE v6.0. Severity classified by CTCAE grade; relationship to study treatment assessed by investigator.
8 secondary outcomes
Objective Response Rate
Time frame: Every 6 weeks thereafter up to 24 months.
Progression-Free Survival (PFS)
Time frame: From date of first dose until the date of first documented progression or death from any cause, whichever occurs first, assessed up to approximately 24 months
Duration of Response
Time frame: From date of first documented response until the date of first documented progression or death, assessed up to approximately 24 months.
Disease Control Rate
Time frame: every 6 weeks thereafter up to 24 months
Overall Survival (OS)
Time frame: From date of first dose until the date of death from any cause, assessed up to approximately 2 years.
Quality of Life- EORTC QLQ-C30 Global Health Status and Functional Scales
Time frame: every 6 weeks thereafter,up to approximately 24 months.
Change in Lymphocyte Subsets and Soluble Immune Mediators
Time frame: At baseline (C0D1; pre-dose) through end of treatment,up to approximately 24 months.
Quality of Life - EQ-5D-5L Utility Index and Visual Analog Scale
Time frame: every 6 weeks thereafter, up to approximately 24 months
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 25 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NK CELLS in people with Advanced Solid Tumors, run by BOE Technology Group Co., Ltd..
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 15 inclusion and 15 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: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ning Li, MD, PhD (8610-87788495, cancergep@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 21 days post first infusion). 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 25 Aug 2026.