Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors

NCT07259889 | Recruiting Phase 1

• 1 other identifier: Xiling Biotechnology Co., Ltd
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors (Phase 1)

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 years after the last administration

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 12 months after the last administration

• Duration of response (DOR)

  Up to 12 months after the last administration

• Disease control rate (DCR)

  12 months after the last administration

• Progression free survival (PFS)

  12 months after the last administration

• Overall survival (OS)

  12 months after the last administration of the last subject

Other Outcomes (7)

• Cytokine(including but not limited to: IL-1 β, IL-2, IL-6, IL-10, TNF - α, IFN - γ)

  up to 48 Days after administration

• Absolute counts of NK cells, T cells, B cells, Th cells, and CTLs

  Up to 48 Days after administration

• Anti-drug antibody (ADA)

  Up to 48 Days after administration

Study Arms (3)

Dose group 1

EXPERIMENTAL

The specification of CEL001 injection is: 20ml per bag, containing approximately 5×10\^8\~1 × 10\^9 NK cells; Encapsulated in cryovials and stored in liquid nitrogen at -196 ° C. There was only one participant in this group. After thawing at 37 ℃, CEL001 injection was administered intravenously with 5 × 10\^8 cells/person/time. Administer once via intravenous infusion at Day 1, Day 20, Day 24, and Day 28, for a total of four doses.

Drug: NK cell preparation

Dose group 2

EXPERIMENTAL

The specification of CEL001 injection is: 20ml per bag, containing approximately 5×10\^8\~1 × 10\^9 NK cells; Encapsulated in cryovials and stored in liquid nitrogen at -196 ° C. There will be three or six participants in this group. After thawing at 37 ℃, CEL001 injection was administered intravenously with 2×10\^9 cells/person/time. Administer once via intravenous infusion at Day 1, Day 20, Day 24, and Day 28, for a total of four doses.

Drug: NK cell preparation

Dose group 3

EXPERIMENTAL

The specification of CEL001 injection is: 20ml per bag, containing approximately 5×10\^8\~1× 10\^9 NK cells; Encapsulated in cryovials and stored in liquid nitrogen at -196 ° C. There will be three or six participants in this group. After thawing at 37 ℃, CEL001 injection was administered intravenously with 5×10\^9 cells/person/time. Administer once via intravenous infusion at Day 1, Day 20, Day 24, and Day 28,for a total of four doses.

Drug: NK cell preparation

Interventions

NK cell preparation DRUG

CEL001 injection

Also known as: CEL001 injection

Dose group 1; Dose group 2; Dose group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to enter this study:
• 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;
• Expected survival time exceeds 3 months;
• There must be at least one measurable lesion, defined as measurable according to the RECIST 1.1 standard;
• Prior to treatment, the main organ function meets the following criteria (no blood transfusion, long-acting EPO, or long-acting G-CSF treatment received within 14 days prior to the administration of the investigational drug, which can be reduced to 7 days for short acting EPO or G-CSF):
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• Blood routine: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelets ≥ 90 × 10\^9/L, hemoglobin ≥ 90 g/L or ≥ 5.6 mmol/L;
• Kidney: serum creatinine ≤ 1.5 x upper limit of normal range (ULN) or Ccr ≥ 50 mL/min (estimated according to the Cockcroft Gault formula);
• Liver: Total bilirubin ≤ 1.5 × ULN (including liver metastasis or liver cancer subjects), AST and ALT ≤ 2.5 × ULN (including liver metastasis or liver cancer subjects ≤ 5 × ULN);
• Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN, Partially Activated Thromboplastin Time (APTT) ≤ 1.5 × ULN; 8. Women should agree to take appropriate contraceptive measures (such as intrauterine devices \[IUDs\], birth control pills, or condoms) during the study period and within 6 months after the end of the study. They must have a negative serum pregnancy test within 7 days prior to enrollment in the study and must be non lactating subjects; Men should agree to take appropriate contraceptive measures during the study period and within 6 months after the end of the study.
• Standard treatment failure:
• Non small cell lung cancer: (1) Subjects with metastatic non driver gene mutations: disease progression or recurrence after at least second-line treatment (including platinum based chemotherapy); (2) Subjects with driver gene mutations such as EGFR, ROS1, ALK in tumors should have received targeted therapy for these mutations that failed, followed by at least second-line treatment (including platinum based chemotherapy) for disease progression or recurrence;

You may not qualify if:

• Subjects who meet any of the following criteria will not be eligible to enter this study:
• 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);
• The adverse reactions of previous anti-tumor treatments have not yet recovered to NCI CTCAE v5.0 grade evaluation ≤ 1 (excluding toxicity judged by researchers to have no safety risks such as hair loss);
• Have undergone surgical procedures within 4 weeks prior to receiving treatment or have not fully recovered from any previous invasive procedures;
• Individuals with active infection (NCI CTCAE v5.0 ≥ 2) or any other suspected infection risk assessed by researchers;
• Have a history of autoimmune diseases, immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Subjects with active hepatitis B or active hepatitis C;
• Individuals who have previously received immunotherapy;
• Have a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (requiring clinical intervention for ventricular arrhythmias, grade II-III atrioventricular block, etc.), myocardial infarction, history of coronary artery bypass surgery, heart failure, New York Heart Association (NYHA) classification of grade II or above, left ventricular ejection fraction (LVEF) ≤ 50% and thrombotic findings, male QTcF\>450msec or female QTcF\>470msec, etc; Subjects with a history of severe cerebrovascular disease such as stroke;
• It is necessary to combine other anti-tumor treatments (including various radiotherapy, chemotherapy, immunotherapy, targeted therapy, traditional Chinese medicine treatment, etc.);
• Have a clear history of neurological or mental disorders, including epilepsy or dementia;
• The researchers believe that there are other reasons why the subjects are not suitable to participate in this clinical study.

Sponsors & Collaborators

• Guangzhou Xiling Biotechnology Co., Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Study Officials

• Li Ning, Ph.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Ning, Ph.D.

CONTACT

8610-87788713; lining@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)