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

ConditionsNSCLC (Advanced Non-small Cell Lung Cancer)Colorectal CancerAdvanced 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • NK Cells

    Biological/Vaccine

    Administered according to standard clinical practice and product labeling

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

    Biological/Vaccine

    3-week cycles

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

    Biological/Vaccine

    2-week cycles

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Cohort 1:Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 2 interventions
Group C: Cohort 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
During the first treatment cycle (21 days for Cohorts 1&3, 14 days for Cohort 2)
2

Adverse Events (AE)

Incidence and severity of treatment-emergent adverse events assessed by NCI-CTCAE v5.0

Time frame
From first dose through 30 days after last dose

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-Free Survival (PFS)

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

Objective Response Rate (ORR)

Proportion of patients achieving complete response (CR) or partial response (PR) per RECIST 1.1

Time frame
From enrollment until disease progression or death, up to 2 years
3

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

Time frame
up to 24 months
4

Disease Control Rate (DCR)

Proportion of patients with CR, PR, or stable disease (SD)

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BOE Technology Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: