NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1/2NCT07551778
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
A Phase 1/2 study testing NK Cells, NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy and NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy in people with NSCLC (Advanced Non-small Cell Lung Cancer) and Colorectal Cancer, run by BOE Technology Group Co., Ltd..
Trial summary
This is a prospective, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of allogeneic natural killer (NK) cell injection combined with standard maintenance therapy in patients with locally advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), Colorectal Cancer, Advanced Solid Tumors
- What is being tested?
- NK Cells, NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy and NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Apr 2029
- Phase
- Phase 1/2
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 18-75 years, either gender
- Subjects must meet one of the following conditions:
- Cohort 1, Cohort 3:
- Histologically/cytologically confirmed locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (Stage IIIB~IV), without known drug-targetable driver mutations (including but not limited to: EGFR sensitive mutations, ALK gene rearrangements, ROS1 mutations, BRAF 600E mutations, KRAS mutations);
- Previously received 4~6 cycles of first-line induction therapy with PD-(L)1 combined with pemetrexed and platinum (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1).
- Cohort 2:
Show all 27Show fewer
- Histologically/cytologically confirmed locally advanced unresectable or metastatic (unresectable Stage III or Stage IV per AJCC 8th Edition) colorectal adenocarcinoma;
- Previously received 6~9 cycles of first-line induction therapy with cetuximab/bevacizumab combined with FOLFOX/FOLFIRI (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1).
- Cohort 4:
- Histologically/cytologically or clinically diagnosed (by dynamic enhanced MRI/dynamic enhanced CT scan, etc.) locally advanced unresectable or metastatic hepatocellular carcinoma;
- Barcelona Clinic Liver Cancer (BCLC) Stage C or Stage B (not suitable for surgery/locoregional therapy, including ablation, intervention, and radiotherapy);
- Child-Pugh score ≤ 7 (Child-Pugh A/B), with no history of hepatic encephalopathy;
- No prior systemic anti-tumor therapy for HCC;
- According to RECIST 1.1, at least one measurable lesion exists: non-lymph node lesion long diameter ≥ 1.0 cm, or lymph node lesion short diameter ≥ 1.5 cm; lesions that have received locoregional therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence confirming definite progression of the lesion.
- Cohort 5:
- Pathologically histologically or cytologically diagnosed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, with HER2 low or negative expression;
- Previously received 6~9 cycles of first-line induction therapy with PD-(L)1 combined with oxaliplatin and fluoropyrimidine-based chemotherapy (cycles not combined with chemotherapy are not counted as combined treatment cycles), and imaging assessment shows non-progressive disease (i.e., CR, PR, or SD per RECIST 1.1).
- Prior neoadjuvant/adjuvant chemotherapy is permitted, provided that disease recurrence or metastasis occurs more than 6 months after the last dose of chemotherapy
- Adequate bone marrow and organ function:
- ANC ≥1.5×10⁹/L; Platelet >90×10⁹/L; Hemoglobin >9 g/dL
- Liver function: Total bilirubin <1.5×ULN; ALT and AST <3×ULN (<5×ULN if liver metastases present)
- Renal function: Serum creatinine ≤1.5×ULN
- Coagulation: PT, APTT, INR <1.5×ULN
- ECOG performance status 0-1
- Life expectancy ≥3 months
- Non-pregnant, non-lactating; women of childbearing potential must have negative serum pregnancy test within 7 days before cell infusion and agree to use reliable contraception during study and for 6 months after last infusion; men with partners of childbearing potential must agree to use reliable contraception
- Voluntary informed consent and able to comply with follow-up
Who cannot join
- Prior treatment with other cellular therapy products (DC, CIK, T cells, NK cells, CAR-T, etc.) except this product
- Other malignancies within 5 years before screening (completely resolved carcinoma in situ and slowly progressing malignancies as determined by investigator excluded)
- Symptomatic moderate to severe third-space effusion requiring therapeutic drainage
- Gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months
- As assessed by the investigator, intrahepatic tumor mass occupies more than 50% of the entire liver, or tumor thrombus invades major blood vessels (such as the main portal vein, superior mesenteric vein, or inferior vena cava), leading to complications such as portal hypertension or related clinical risks.
- Significant cardiovascular disease history including
Show all 13Show fewer
- Arterial or venous thrombotic events within 6 months before enrollment (CVA, DVT, PE, etc.)
- Active infection (viral, bacterial, fungal) currently being treated, or any infection requiring IV antibiotics for ≥7 days within past 6 weeks, or oral antibiotics within past 1 week
- Active autoimmune disease or history of severe autoimmune disease requiring long-term immunosuppression
- Participation in other interventional clinical trials within 3 months
- Toxicities from prior interventions not resolved to Grade ≤2 (alopecia excluded)
- Untreated chronic active hepatitis B, chronic HBV carriers with HBV DNA ≥1000 copies/mL; HCV antibody positive with HCV-RNA positive; HIV antibody positive; syphilis antibody positive
- Any other condition deemed by investigator to make subject unsuitable for study participation
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 Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic NK Cell Injection Combined With Standard Maintenance Therapy in Subjects With Locally Advanced or Metastatic Solid Tumors
This is a prospective, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of allogeneic natural killer (NK) cell injection combined with standard maintenance therapy in patients with locally advanced or metastatic solid tumors. The study consists of 5 cohorts: Cohort 1 (advanced non-squamous NSCLC with NK cells + PD-(L)1 inhibitor + pemetrexed), Cohort 2 (advanced colorectal adenocarcinoma with NK cells + cetuximab/bevacizumab + capecitabine), Cohort 3 (lymphodepletion exploration cohort with fludarabine + cyclophosph preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed), Cohort 4 (advanced HCC with NK cells + VEGF + PD-(L)1), and Cohort 5 (advanced GC with NK cells + PD-(L)1 + S-1).
Read the detailed description
This study is designed as a prospective cohort study to evaluate the safety and efficacy of allogeneic NK cell injection combined with standard maintenance therapy in advanced solid tumor patients.
Study Design:
Cohort 1: Advanced non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations, receiving NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy (3-week cycles) Cohort 2: Advanced colorectal adenocarcinoma, receiving NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy (2-week cycles) Cohort 3: Lymphodepletion exploration cohort for advanced non-squamous NSCLC, receiving fludarabine + cyclophosphamide preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed (3-week cycles) Each cohort includes a safety lead-in phase (3 patients) followed by an expansion phase (3-6 patients). Dose-limiting toxicity (DLT) will be assessed during the first cycle.
Cohort 4 :advanced HCC with NK cells + VEGF + PD-(L)1 (3-week cycles). Cohort 5 :advanced GC with NK cells + PD-(L)1 + S-1 (2-week cycles).
- Conditions
- NSCLC (Advanced Non-small Cell Lung Cancer), Colorectal Cancer, Advanced Solid Tumors, Advanced Hepatocellular Carcinoma (HCC), GC/GEJC
- Being tested
- NK Cells, NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy, NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy, NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy, NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK CellsBiological
Administered according to standard clinical practice and product labeling
NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapyBiological
3-week cycles
NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapyBiological
2-week cycles
NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapyBiological
3-week cycles
NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapyBiological
2-week cycles
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: | Experimental | NK cells + PD-(L)1 inhibitor + pemetrexed Receives: Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy |
| Cohort 2 | Experimental | NK cells + cetuximab/bevacizumab + capecitabine Receives: Biological: NK Cells; Biological: NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy |
| Cohort 3 | Experimental | Lymphodepletion exploration cohort Receives: Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy |
| Cohort 4 | Experimental | NK+ PD-(L)1 + VEGF inhibitor Receives: Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + VEGF inhibitor as first-line maintenance therapy |
| Cohort 5 | Experimental | NK +PD-(L)1+ chemotherapy Receives: Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + capecitabine or S-1 as first-line maintenance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Incidence of DLT defined as: Grade 4-5 CRS or ICANS related to NK cells; Grade 3 CRS/ICANS not resolving to ≤Grade 2 within 7 days; Grade ≥3 non-hematologic toxicity not resolving to Grade 2 or baseline; Grade 4 hematologic toxicity not resolving to Grade 2 or baseline within DLT observation period
Measured: During the first treatment cycle (21 days for Cohorts 1&3, 14 days for Cohort 2)
Adverse Events (AE)
Incidence and severity of treatment-emergent adverse events assessed by NCI-CTCAE v5.0
Measured: From first dose through 30 days after last dose
Secondary outcomes (7)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: From enrollment until disease progression or death, up to 2 years
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1
Measured: From enrollment until disease progression or death, up to 2 years
Duration of Response (DOR)
From date of first documented response (CR or PR) until date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Measured: up to 24 months
Disease Control Rate (DCR)
Proportion of patients with CR, PR, or stable disease (SD)
Measured: Up to 2 years
Circulating Tumor DNA (ctDNA) Changes
Changes in peripheral blood ctDNA levels
Measured: Baseline, every 6 weeks during treatment (up to approximately 12 months), and at end of treatment, up to 12 months
Quality of Life EORTC QLQ-C30
Changes in EORTC QLQ-C30 scores
Measured: Baseline, every 6 weeks during treatment, and at end of treatment, up to 24 months
Quality of Life EORTC EQ-5D-5L
Changes in EQ-5D-5L utility index score
Measured: Baseline, every 6 weeks during treatment, and at end of treatment,up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT07551778
- Sponsor's protocol ID
- BOETech
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided