Solid Tumors, AdultPhase 1NCT06897228
PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
A Phase 1 study testing PANK-003 cell injection in people with Solid Tumors, Adult, run by Shenzhen Celconta Life Science Co., Ltd. at 1 site in China.
Trial summary
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- PANK-003 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to Mar 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form;
- At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;
- Patients who have been histologically confirmed or diagnosed by imaging (computed tomography (CT) examination, magnetic resonance imaging (MRI) examination or positron emission tomography (PET) scan CT (PET/CT)) as postoperative patients with malignant solid tumors;
- Patients who have undergone surgical treatment and are going to receive or are currently undergoing postoperative adjuvant chemotherapy;
- At the time of enrollment, the expected survival time is more than 6 months;
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;
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- At the time of screening, the laboratory tests should meet the following requirements:
- White blood cell count ≥ 3.0×10⁹/L;
- Neutrophil count ≥ 1.5×10⁹/L;
- Lymphocyte count ≥ 0.5×10⁹/L;
- Hemoglobin ≥ 90 g/L;
- Platelets ≥ 75×10⁹/L;
- Serum total bilirubin ≤ 2.0× the upper limit of normal value (ULN). For patients with a history of Gilbert's syndrome/suspected of having the disease, the total bilirubin (TBIL) should be ≤ 3×ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;
- Creatinine < 1.5×ULN and endogenous creatinine clearance rate ≥ 50 mL/minute (Cockcroft-Gault method for calculating creatinine clearance rate: For men, creatinine clearance rate = [(140 - age) × body weight (kg)] / [0.818 × creatinine (μmol/L)]; For women, creatinine clearance rate = [(140 - age) × body weight (kg) × 0.85] / [0.818 × creatinine (μmol/L)]);
- Good lung function, with a baseline fingertip pulse oximetry saturation ≥ 95% in an indoor air environment;
- Female subjects of childbearing age must undergo a serum pregnancy test at the time of screening with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study period and for at least 1 year after the last study treatment. For male subjects whose partners are of childbearing age, they should have undergone surgical sterilization or agree to use an effective contraceptive method during the study period and for at least 1 year after the last study treatment;
- Be evaluated by the investigator as suitable for inclusion in this clinical study.
Who cannot join
- Pregnant or lactating women;
- Individuals with a history of allergy to any component of the cell product;
- Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg), positive for hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the lower limit of measurability; positive for hepatitis C antibody (HCV-Ab); positive for Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody test; anyone meeting any one of these items;
- Patients who have received drugs from other clinical trials or other cellular immunotherapies within 28 days before the screening period;
- Those who have received live vaccines or live attenuated vaccines within 4 weeks before NK cell infusion;
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- Patients with comorbidities that, in the judgment of the investigator, require treatment with systemic corticosteroids or other immunosuppressive drugs during the study period;
- Individuals with a high allergic constitution, those allergic to any component of the NK preparation product, including those allergic to serum albumin; those allergic to commonly used emergency and anesthetic drugs;
- Having any unstable circulatory system diseases within 180 days before screening, including but not limited to unstable angina pectoris, myocardial infarction, heart failure [New York Heart Association (NYHA) class ≥ III], severe arrhythmia requiring drug treatment, or having undergone angioplasty, coronary artery stent implantation, or coronary artery bypass grafting within 180 days before screening;
- Diseases or other situations that the investigator deems unsuitable for this clinical study (such as high allergic constitution, poorly controlled diabetes mellitus, uncontrolled infections, presence of central nervous system diseases, bleeding and thrombotic tendencies; as well as poor compliance, drug abuse, etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
AnYang Tumor Hospital
Anyang, Henan, 455000
Baozhong Li, 13937238883, libaozhong99@126.com
About this study
Official title: A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors
Read the detailed description
This project is a prospective, single-arm, open-label, single-dose, multiple-administration dose-finding study, which aims to evaluate the safety, tolerability, and efficacy characteristics of the PANK-003 cell preparation in subjects after adjuvant chemotherapy following surgery for solid tumors.
The study will enroll subjects with pathologically diagnosed solid tumors (lung cancer, esophageal cancer, gastric cancer, breast cancer) who have received adjuvant chemotherapy after surgical treatment or after neoadjuvant therapy plus surgical treatment.
The study includes a screening period, a treatment period, and an observation and follow-up period.
The main objectives :
To evaluate the safety and tolerability of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors.
The secondary objectives :
To preliminarily evaluate the efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors.
- Conditions
- Solid Tumors, Adult
- Being tested
- PANK-003 cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANK-003 cell injectionDrug
PANK-003 cell injection
| Study group | Role | What they receive |
|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Experimental | PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy Receives: Drug: PANK-003 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Measured: 21 days after the completion of a single administration
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest
Measured: 1 year
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Measured: 21 days after the completion of a single administration
Secondary outcomes (2)
Evaluate the disease - free survival (DFS)
The time from the date of first administration of PANK-003 cell injection to tumor recurrence or death from any cause
Measured: 1 year
Evaluate the overall survival (OS)
The time from the date of first administration of PANK-003 cell injection to death from any cause
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start18 Feb 2024
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897228
- Sponsor's protocol ID
- 2024YP01H01
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
- ClinicalTrials.gov ID
- NCT06897228
- Acronym / sponsor ID
- 2024YP01H01
- Conditions
- Solid Tumors, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shenzhen Celconta Life Science Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Mar 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.
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors
Detailed description
This project is a prospective, single-arm, open-label, single-dose, multiple-administration dose-finding study, which aims to evaluate the safety, tolerability, and efficacy characteristics of the PANK-003 cell preparation in subjects after adjuvant chemotherapy following surgery for solid tumors.
The study will enroll subjects with pathologically diagnosed solid tumors (lung cancer, esophageal cancer, gastric cancer, breast cancer) who have received adjuvant chemotherapy after surgical treatment or after neoadjuvant therapy plus surgical treatment.
The study includes a screening period, a treatment period, and an observation and follow-up period.
The main objectives :
To evaluate the safety and tolerability of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors.
The secondary objectives :
To preliminarily evaluate the efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy | Experimental | Drug: PANK-003 cell injectionPANK-003 cell injection combined with standard postoperative adjuvant chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Understand and voluntarily sign the informed consent form;
- At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;
- Patients who have been histologically confirmed or diagnosed by imaging (computed tomography (CT) examination, magnetic resonance imaging (MRI) examination or positron emission tomography (PET) scan CT (PET/CT)) as postoperative patients with malignant solid tumors;
- Patients who have undergone surgical treatment and are going to receive or are currently undergoing postoperative adjuvant chemotherapy;
- At the time of enrollment, the expected survival time is more than 6 months;
Key exclusion criteria (10 listed)
- Pregnant or lactating women;
- Individuals with a history of allergy to any component of the cell product;
- Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
- Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg), positive for hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the lower limit of measurability; positive for hepatitis C antibody (HCV-Ab); positive for Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody test; anyone meeting any one of these items;
- Patients who have received drugs from other clinical trials or other cellular immunotherapies within 28 days before the screening period;
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 |
|---|---|---|
| PANK-003 cell injectionPANK-003 cell injection | Drug | PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 21 days after the completion of a single administration
Dose limiting toxicity (DLT) in the dose escalation phase
Incidence of Treatment Related adverse events (AEs)
Time frame: 1 year
Incidence of Treatment Related AEs, AEs of special interest
Maximum tolerated dose (MTD)
Time frame: 21 days after the completion of a single administration
Maximum tolerated dose (MTD) in the dose escalation phase
2 secondary outcomes
Evaluate the disease - free survival (DFS)
Time frame: 1 year
Evaluate the overall survival (OS)
Time frame: 1 year
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 26 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 PANK-003 cell injection in people with Solid Tumors, Adult, run by Shenzhen Celconta Life Science 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 18 inclusion and 10 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 26 Mar 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 Baozhong Li (139372338883, libaozhong99@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 21 days after the completion of a single administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2025.