This study is the first human, open label, dose escalation, and expansion phase I clinical trial aimed at evaluating the safety, tolerability, preliminary efficacy, pharmacokinetic characteristics, biomarker changes, and immunogenicity of CEL001 injection in the treatment of advanced solid tumors.
Age ≥ 18 years old, gender not limited;
ECOG physical fitness status score: 0-1 points;
Subjects with advanced or metastatic tumors diagnosed by histology or cytology, who have failed* or unable to tolerate standard treatment according to CSCO guidelines or NCCN guidelines, or lack effective treatment methods;
Male subjects should weigh no less than 50 kilograms, and female subjects should weigh no less than 45 kilograms;
Individuals allergic to any component of CEL001 injection, including those allergic to penicillin;
Have received anti-tumor treatments such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or participated in other clinical trials within 4 weeks or 5 known drug half lives (whichever is shorter) before the first use of the investigational drug;
Have received traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the instructions within 14 days before the first administration;
Within the past 5 years, have had malignant tumors other than those treated in this study (excluding cured thyroid cancer, basal cell carcinoma of the skin, and cervical carcinoma in situ);
Sequential
NK cell preparation
DrugCEL001 injection
Treatment related adverse events (AEs) and serious adverse events (SAEs)
The incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) after CEL001 injection infusion.
Objective response rate (ORR)
The objective response rate (ORR) is defined as the proportion of participants who achieve complete response (CR) and partial response (PR), which is the optimal overall response.
Duration of response (DOR)
Duration of response (DOR) is defined as the time interval (in months) from the first assessment of a tumor as CR or PR (confirmed response) to the first objective record of disease progression (PD) or death from any cause.
Disease control rate (DCR)
The disease control rate (DCR) defines the optimal overall efficacy as the proportion of participants who achieve complete response (CR), partial response (PR), and disease stability (SD).
Progression free survival (PFS)
Progression free survival (PFS) is defined as the time interval (in months) between participants receiving study treatment for the first time and experiencing disease progression or death from any cause, whichever occurs first.
Cytokine(including but not limited to: IL-1 β, IL-2, IL-6, IL-10, TNF - α, IFN - γ)
To assess changes in systemic cytokine levels following administration of CEL001 Injection in patients with advanced solid tumors. Concentrations of target cytokines (IL-1β, IL-2, IL-6, IL-10, TNF-α, IFN-γ) will be measured via validated multiplex immunoassay at baseline and 48 days post the first dose (or key treatment cycles). The outcome will include the concentration of each cytokine and changes from baseline, with a focus on potential cytokine release-related signals.
Absolute counts of NK cells, T cells, B cells, Th cells, and CTLs
To assess changes in peripheral blood immune cell populations following administration of CEL001 Injection in patients with advanced solid tumors. Absolute counts of NK cells, T cells, B cells, Th cells, and CTLs will be measured via validated flow cytometry at baseline and post-treatment (end of study or early termination). The primary focus is to document the absolute count values of each cell subset and their changes from baseline.
Anti-drug antibody (ADA)
To assess the immunogenicity of CEL001 cells in patients with advanced solid tumors by detecting treatment-induced anti-drug antibodies (ADA) against infused cells or their associated components. Serum samples will be collected at pre-specified time points: baseline (prior to cell infusion), post-infusion (Day 20), and up to 48 days post-infusion. Samples will be analyzed using a validated tiered bioanalytical assay (screening for binding ADA, confirmation of specificity, and titer determination). Outcomes include the incidence of ADA positivity, titer dynamics, and neutralizing antibody (Nab) status (if tested).
Cmax
To determine the peak peripheral blood concentration (Cmax) of viable CEL001 cells in patients with advanced solid tumors. Peripheral blood samples will be collected at pre-specified time points up to 336 hours post-infusion and analyzed using a validated flow cytometry method to quantify viable infused cells. Cmax is defined as the highest measured concentration of viable CEL001 cells in peripheral blood during the sampling period, reported in units of cells/μL(microliter). This parameter will characterize the in vivo engraftment peak of CEL001 cells, supporting the assessment of cell survival, activation, and optimal dosing schedules for future clinical studies.
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