Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors (NCT07551778) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
20 participantsStarted 2026-05
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-Limiting Toxicity (DLT)
Timeframe: During the first treatment cycle (21 days for Cohorts 1&3, 14 days for Cohort 2)
2
Adverse Events (AE)
Timeframe: From first dose through 30 days after last dose
. 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:
Exclusion criteria
. 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