Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors

NCT07551778 | Not Yet Recruiting Phase 1

• 1 other identifier: BOETech
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. The study consists of three 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), and Cohort 3 (lymphodepletion exploration cohort with fludarabine + cyclophosph preconditioning followed by NK cells + PD-(L)1 inhibitor + pemetrexed).

Conditions

Colorectal Cancer; Advanced Solid Tumors; NSCLC (Advanced Non-small Cell Lung Cancer)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From first dose through 30 days after last dose

Secondary Outcomes (7)

• Progression-Free Survival (PFS)

  From enrollment until disease progression or death, up to 2 years

• Objective Response Rate (ORR)

  From enrollment until disease progression or death, up to 2 years

• Duration of Response (DOR)

  up to 24 months

• Disease Control Rate (DCR)

  Up to 2 years

• Circulating Tumor DNA (ctDNA) Changes

  Baseline, every 6 weeks during treatment (up to approximately 12 months), and at end of treatment, up to 12 months

Study Arms (3)

Cohort 1:

EXPERIMENTAL

NK cells + PD-(L)1 inhibitor + pemetrexed

Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy

Cohort 2

EXPERIMENTAL

NK cells + cetuximab/bevacizumab + capecitabine

Biological: NK Cells; Biological: NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy

Cohort 3

EXPERIMENTAL

Lymphodepletion exploration cohort

Biological: NK Cells; Biological: NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy

Interventions

NK Cells BIOLOGICAL

Administered according to standard clinical practice and product labeling

Cohort 1:; Cohort 2; Cohort 3

NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy BIOLOGICAL

3-week cycles

Cohort 1:; Cohort 3

NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy BIOLOGICAL

2-week cycles

Cohort 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years, either gender
• Cohort 1 \& 3: Histologically or cytologically confirmed locally advanced unresectable or metastatic non-squamous NSCLC (Stage IIIB-IV) without known actionable driver gene mutations (including but not limited to: EGFR sensitizing mutations, ALK rearrangement, ROS1 rearrangement, BRAF V600E mutation, KRAS mutation)
• Cohort 1 \& 3: Previously received 4-6 cycles of first-line induction therapy with PD-(L)1 inhibitor combined with pemetrexed plus platinum, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)
• Cohort 2: Histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma (unresectable Stage III or Stage IV per AJCC 8th edition)
• Cohort 2: Previously received 6-9 cycles of first-line induction therapy with cetuximab or bevacizumab combined with FOLFOX or FOLFIRI, with radiographic assessment of non-progressive disease (CR, PR, or SD per RECIST 1.1)
• Prior neoadjuvant/adjuvant chemotherapy allowed if disease recurrence or metastasis occurred \>6 months after last chemotherapy dose
• At least one measurable lesion per RECIST 1.1 (except patients who achieved CR during induction therapy): non-lymph node lesion ≥1.0 cm in longest diameter, or lymph node lesion ≥1.5 cm in short diameter; lesions treated with local therapy (radiation or interventional) cannot be target lesions unless progression is documented
• 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

You may not qualify if:

• 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
• Significant cardiovascular disease history including
• 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

Sponsors & Collaborators

• BOE Technology Group Co., Ltd.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Interventions

Pemetrexed; Cetuximab; Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Ning Li, MD, PhD

CONTACT

0316-5918497; lfcancergcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04