Allogeneic NK Cell Therapy Combined With Standard Maintenance Treatment in Advanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBOE Technology Group Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- NK Cells
- NK cells + PD-(L)1 inhibitor + pemetrexed as first-line maintenance therapy
- NK cells + cetuximab/bevacizumab + capecitabine as first-line maintenance therapy
Treatment groups
20 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov