Advanced Solid Tumors (Phase 1)Phase 1NCT07259889

Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors

A Phase 1 study testing NK cell preparation in people with Advanced Solid Tumors (Phase 1), run by Guangzhou Xiling Biotechnology Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors (Phase 1)
What is being tested?: NK cell preparation
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteChina
Study dates: 16 Jun 2025to 15 Jun 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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):
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;
Small cell lung cancer: disease progression or recurrence after receiving at least second-line treatment in the past;
Colorectal cancer: disease progression or recurrence after at least second-line treatment in the past (standard chemotherapy regimens include fluorouracil or its derivatives, oxaliplatin, and irinotecan, Subjects with BRAF V600E mutation have used BRAF inhibitors, and subjects with MSI-H/dMMR need to have used PD-1/PD-L1 treatment);
Head and neck squamous cell carcinoma: disease progression or recurrence after receiving at least second-line treatment (including platinum based chemotherapy) in the past;
Urethral epithelial cancer: disease progression or recurrence after receiving at least second-line treatment in the past (recommended treatment regimens in guidelines include PD-1/PD-L1 therapy, platinum based chemotherapy regimen, paclitaxel based chemotherapy regimen, vediximab, and vinblastine, and subjects with FGFR2/3 mutations have already used edatinib);
Esophageal cancer: disease progression or recurrence after receiving at least second-line treatment (including platinum based chemotherapy) in the past;
Cervical cancer: disease progression or recurrence after receiving at least second-line treatment in the past (including platinum based chemotherapy, subjects who meet PD-L1 positive or TMB-H or MSI-H/dMMR criteria must have received PD-1/PD-L1 treatment);
Hepatocellular carcinoma: disease progression or recurrence after receiving at least second-line treatment in the past;
Renal cell carcinoma: disease progression or recurrence after receiving at least second-line treatment in the past;
For other unspecified malignant tumors, refer to the latest guidelines of CSCO or NCCN.

Who cannot join

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);

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Have undergone surgical procedures within 4 weeks prior to receiving treatment or have not fully recovered from any previous invasive procedures;
If there are clinical symptoms of central nervous system metastasis or meningeal metastasis, or if there is other evidence indicating that the participant's central nervous system metastasis or meningeal metastasis has not been controlled, the researcher determines that it is not suitable for inclusion;
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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Ning, Ph.D. contact

8610-87788713

lining@cicams.ac.cn

China1 site, 1 recruiting

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, 100021
Li Ning, Ph.D., 8610-87788713, lining@cicams.ac.cn
Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Study Evaluating the Safety and Tolerability of CEL001 Injection in the Treatment of Advanced Solid Tumors

Read the detailed description

This study is divided into five stages: screening period, single dose period, clearing period, multiple dose period, and follow-up period. The observation period for single dose DLT is tentatively set at 14 days after administration, while the observation period for multiple dose DLT is tentatively set at 28 days after the first dose of multiple doses. The cumulative administration time from a single dose is tentatively set at no more than 1 year, and the follow-up period is tentatively set at 2 years after the last dose.

Conditions: Advanced Solid Tumors (Phase 1)
Being tested: NK cell preparation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NK cell preparationDrug
Also called CEL001 injection
CEL001 injection

Study groups in NCT07259889
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: NK cell preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 2 years after the last administration

Secondary outcomes (5)

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.
Measured: Up to 12 months after the last administration
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.
Measured: Up to 12 months after the last administration
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).
Measured: 12 months after the last administration
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.
Measured: 12 months after the last administration
Overall survival (OS)
The overall survival (OS) is defined as the time interval (in months) between the first treatment and death from any cause.
Measured: 12 months after the last administration of the last subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jun 202515 Jun 2028

First posted2 Dec 2025
Study start16 Jun 2025
Primary completion15 Jun 2028 (estimated)
Study completion15 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid Tumors (Phase 1)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 13 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07259889
Sponsor's protocol ID: Xiling Biotechnology Co., Ltd
Status last verified: Nov 2025
First submitted: 14 Nov 2025
Last updated: 2 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Li Ning, Ph.D.

8610-87788713

lining@cicams.ac.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 1
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This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
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Not yet recruitingPhase 1
MTX-531-001 Phase 1 Study in Advanced Solid Tumors
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RecruitingPhase 1
A Phase 1 Study of APX-343A as Monotherapy or in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
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A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
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All Advanced Solid Tumors (Phase 1) trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Study Evaluating the Safety and Tolerability of CEL001 Injection in the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07259889
Acronym / sponsor ID: Xiling Biotechnology Co., Ltd
Conditions: Advanced Solid Tumors (Phase 1)
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 13 participants (estimated)
Lead sponsor: Guangzhou Xiling Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Jun 2025 (actual)
Primary completion: 15 Jun 2028 (estimated)
Study completion: 15 Jun 2028 (estimated)
First posted: 2 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dose group 1	Experimental	Drug: NK cell preparationThe 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.
Dose group 2	Experimental	Drug: NK cell preparationThe 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.
Dose group 3	Experimental	Drug: NK cell preparationThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Subjects must meet all of the following criteria to enter this study:

Key exclusion criteria (16 listed)

Subjects who meet any of the following criteria will not be eligible to enter this study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NK cell preparationAlso: CEL001 injectionCEL001 injection	Drug	Dose group 1, Dose group 2, Dose group 3

Primary outcome

Treatment related adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 2 years after the last administration
The incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) after CEL001 injection infusion.

5 secondary outcomes

Objective response rate (ORR)
Time frame: Up to 12 months after the last administration
Duration of response (DOR)
Time frame: Up to 12 months after the last administration
Disease control rate (DCR)
Time frame: 12 months after the last administration
Progression free survival (PFS)
Time frame: 12 months after the last administration
Overall survival (OS)
Time frame: 12 months after the last administration of the last subject

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.

Related trials for Advanced Solid Tumors (Phase 1)

Not yet recruitingPhase 1
A Study to Evaluate YF550 in Participants With Locally Advanced or Metastatic Solid Tumors.
Solid Tumor (Phase I), Ovarian Cancer
RecruitingPhase 1
This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
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Not yet recruitingPhase 1
MTX-531-001 Phase 1 Study in Advanced Solid Tumors
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Not yet recruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
Advanced Solid Tumor (Phase 1)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Li Ning, Ph.D. contact

8610-87788713

lining@cicams.ac.cn

Li Ning, Ph.D. principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NK cell preparation in people with Advanced Solid Tumors (Phase 1), run by Guangzhou Xiling Biotechnology Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Ning, Ph.D. (8610-87788713, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment related adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 2 years after the last administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.