NK Cell Injection for Advanced Solid Tumors

ConditionAdvanced Solid Tumors

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBOE Technology Group Co., Ltd.

About this trial

This is an open-label, single-arm, dose-escalation Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of NK Cell Injection in patients with advanced solid tumors.

Eligible participants who have signed written informed consent will be screened and, if qualified, assigned a enrollment number and sequentially assigned to the designated dose group.

The study employs a traditional "3+3" dose-escalation design. Each dose group enrolls at least 3 participants, with each participant receiving only one corresponding dose level, until the MTD or RP2D is determined.

The study consists of four periods: Screening Period, Treatment Period (including lymphodepleting chemotherapy), Safety Follow-up Period, and Survival Follow-up Period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years (inclusive), regardless of sex;

Histologically or cytologically confirmed advanced solid tumor;

Failed standard treatment, or no standard treatment available, or standard treatment not currently applicable;

At least one measurable lesion per RECIST 1.1 (non-lymph node lesion >= 1.0 cm in long diameter, or lymph node lesion >= 1.5 cm in short diameter); lesions previously treated with local therapy (e.g., radiotherapy or interventional therapy) cannot be considered target lesions unless there is imaging evidence of definitive progression;

Disqualifiers

Other malignancies within 5 years prior to screening (except completely resolved carcinoma in situ and malignancies judged by the investigator to be slow-progressing);

History of leptomeningeal metastasis or CNS metastasis, or definite CNS underlying disease with significant residual symptoms within 6 months prior to cell infusion (asymptomatic brain metastasis or stable symptoms after treatment without corticosteroid use may be allowed);

Clinically symptomatic moderate to severe third-space effusion requiring therapeutic drainage (except for minimal effusion on imaging without clinical symptoms);

Severe cardiovascular disease history, including but not limited to: severe arrhythmia or conduction abnormalities requiring clinical intervention; QTcF > 450 ms (male) or > 470 ms (female); acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other >= Grade 3 cardiovascular events within 6 months prior to screening; NYHA functional classification >= II or LVEF < 50%; uncontrolled hypertension (SBP >= 160 mmHg and/or DBP >= 100 mmHg);

Trial design

Design model

Single group

Treatments tested in this trial

NK CELLS
Biological/Vaccine
Allogeneic natural killer (NK) cell therapy (non-genetically modified)

Treatment groups

9 Participants

are divided into 1 treatment group

Group A: Dose-escalation Phase I clinical studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Dose-limiting toxicity (DLT)

Incidence of DLT assessed during the single-infusion DLT observation period (14 days post single infusion) and the multiple-infusion DLT observation period (first cycle, 21 days). DLT is defined per the protocol-specified DLT criteria.

Time frame

Up to 21 days post first infusion

Maximum tolerated dose (MTD) and recommended Phase II dose (RP2D)

MTD defined as the highest dose level at which ≤33% of DLT-evaluable participants experience DLT, per protocol-specified dose-escalation rules. RP2D determined based on safety, PK, and preliminary activity across completed dose levels.

Time frame

Estimated up to 24 months from first enrollment

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

All-cause AEs and SAEs, including clinically significant laboratory abnormalities, graded per NCI-CTCAE v6.0. Severity classified by CTCAE grade; relationship to study treatment assessed by investigator.

Time frame

From first infusion through end of safety follow-up (approximately 30 days after last infusion)

Secondary outcomes

Objective Response Rate

Proportion of participants with complete response (CR) or partial response (PR) as best overall response per RECIST 1.1. Responses confirmed by repeat imaging ≥ 4 weeks after first documentation.

Time frame

Every 6 weeks thereafter up to 24 months.

Progression-Free Survival (PFS)

Time from first dose to date of first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.

Time frame

From date of first dose until the date of first documented progression or death from any cause, whichever occurs first, assessed up to approximately 24 months

Duration of Response

Time from first documented CR or PR until the date of first documented progression or death from any cause, whichever occurs first, among responders.

Time frame

From date of first documented response until the date of first documented progression or death, assessed up to approximately 24 months.

Disease Control Rate

Proportion of participants with CR, PR, or stable disease (SD) lasting ≥ 8 weeks per RECIST 1.1.

Time frame

every 6 weeks thereafter up to 24 months

Other outcomes

Pharmacokinetic Parameters-Maximum Plasma Concentration (Cmax)

Maximum observed plasma concentration of NK

Time frame

Up to 21 days post each infusion

Immunogenicity

Anti-HLA antibodies

Time frame

From baseline (C0D1; pre-dose) to the end-of-treatment visit,up to approximately 24 months.

Time to Maximum Plasma Concentration (Tmax)

Time to reach maximum observed plasma concentration of NK

Time frame

Up to 21 days post each infusion

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: