Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)Early Phase 1CCT-ANK-11NCT06284226
An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients
A Early Phase 1 study testing Allogeneic NK（CCT-ANK-11) in people with Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer), run by Beijing Kejing Biotechnology Co., Ltd..
Trial summary
An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)
- What is being tested?
- Allogeneic NK（CCT-ANK-11)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2022to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient agrees to complete the entire treatment plan and sign the informed consent form.
- Age 18 to 65, male or female.
- Malignancy confirmed by histology or imaging diagnosis (computer tomography (CT), magnetic resonance imaging (MRI), contrast-enhanced ultrasound, EOB-MRI), the malignant solid tumor was completely resected (R0).
- Patients who have received surgical treatment 4-8 weeks before the screening period.
- Quality of life assessment form (ECOG) score 0,2.
- Child-Pugh score of liver function ≤ 7.
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- The life expectancey is more than 6 months.
- Patients with appropriate hematological functions:
- （1）White blood cell (WBC) ≥ 3000 cells / mm3. （2）Absolute neutrophil count (ANC) ≥ 1500 cells.
- （3）Platelet count (Platelets) ≥ 80000/mm3. （4）Hemoglobin (Hb) ≥ 9g/dl. 9. Patients with appropriate liver and kidney functions:
- （1）Urea nitrogen (BUN) ≤ 1.5 times of the upper limit of normal value (ULN).（2）Serum creatinine (serumcreatinine) ≤ 1.5 times of the upper limit of normal value (ULN).（3）Total bilirubin (TB) ≤ 1.5 times of the upper limit of normal value (ULN).（4）Glutamic pyruvic transaminase (ALT or GPT) and glutamic oxaloacetic transaminase (AST or GOT) ≤ 2.5 times the upper limit of normal value (ULN).
- 10. Patients who have tested negative for syphilis and AIDS. 11.Patient with active hepatitis B, can take antiviral drugs during the trial period.
- twelve。 Fertile men and women must use effective contraception within 14 days after signing the informed consent form and within 14 days after the last dose of natural killer cells are infused.
- 13. At least two forms of birth control must be used, one of which must be a barrier method. Acceptable contraceptive measures include:
- （1）Establish oral, injection or implanted hormone contraceptive methods.（2）Placement of intrauterine device (IUD) or intrauterine system (IUS).（4）Barrier method: condom or occlusive cap (contraceptive diaphragm or cervical / uterine cap).
- 14. The patient agrees to comply to the trial rpotocols.
Who cannot join
- Patients received drugs or other cellular immunotherapy in other clinical trials within 28 days before the screening period.
- Patients are receiving immunosuppressive therapy for previous or recurrent autoimmune diseases within 14 days before allogeneic natural killer cell infusion.
- The patient suffered from other malignant tumors in the past 5 years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
- Acute illness in progress, or has been accompanied by serious diseases in the past 2 years, such as cardiovascular disease (such as New York Heart Association (NYHA) III or IV), mental health problems (e.g. alcohol, drug abuse). Or the program moderator judges patients who are not suitable to participate in clinical trials on the basis of medical history, physical examination results or test abnormalities that may interfere with the test results or adversely affect the safety of the subjects.
- Allergic to aminoglycosides (Aminoglycoside) or subtilisin (Bacitracin), such as streptomycin (Streptomycin) and gentamicin (Gentamicin).
- Patient is known to be allergic to any ingredient in the end product of NK preparation, including human serum albumin.
- Female subjects who are breast-feeding or positive for serum or urine pregnancy tests during the screening period.
- Pretreatment with steroids or antihistamines cannot be controlled for radiographic contrast agents (iodinated or non-iodinated) who have a history of allergy or allergic reactions or other clinically significant adverse reactions, and the researchers believe that it is not suitable for subjects who undergo conventional computerized tomography (CT) or magnetic resonance imaging (MRI). And subjects with contraindications for CT scanning for other reasons (such as strong magnetic implants, severe claustrophobia) should not be included in the group.
About this study
An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients
- Being tested
- Allogeneic NK（CCT-ANK-11)
- Medical subject headings
- Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Cholangiocarcinoma, Lung Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic NK（CCT-ANK-11)Drug
allogeneic natural killer cells
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | Not described Receives: Drug: Allogeneic NK（CCT-ANK-11) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and the efficacy
To evaluate the safety and objective remission rate of multiple injections of allogeneic natural killer cells (complete remission [CR] + partial remission [PR])
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Mar 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The project is terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer)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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Kejing Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284226
- Sponsor's protocol ID
- CCT-ANK-11
- Acronym
- CCT-ANK-11
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT06284226
- Acronym / sponsor ID
- CCT-ANK-11 / CCT-ANK-11
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project is terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Kejing Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: Allogeneic NK（CCT-ANK-11) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The patient agrees to complete the entire treatment plan and sign the informed consent form.
- Age 18 to 65, male or female.
- Malignancy confirmed by histology or imaging diagnosis (computer tomography (CT), magnetic resonance imaging (MRI), contrast-enhanced ultrasound, EOB-MRI), the malignant solid tumor was completely resected (R0).
- Patients who have received surgical treatment 4-8 weeks before the screening period.
- Quality of life assessment form (ECOG) score 0,2.
Key exclusion criteria (8 listed)
- Patients received drugs or other cellular immunotherapy in other clinical trials within 28 days before the screening period.
- Patients are receiving immunosuppressive therapy for previous or recurrent autoimmune diseases within 14 days before allogeneic natural killer cell infusion.
- The patient suffered from other malignant tumors in the past 5 years (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix).
- Acute illness in progress, or has been accompanied by serious diseases in the past 2 years, such as cardiovascular disease (such as New York Heart Association (NYHA) III or IV), mental health problems (e.g. alcohol, drug abuse). Or the program moderator judges patients who are not suitable to participate in clinical trials on the basis of medical history, physical examination results or test abnormalities that may interfere with the test results or adversely affect the safety of the subjects.
- Allergic to aminoglycosides (Aminoglycoside) or subtilisin (Bacitracin), such as streptomycin (Streptomycin) and gentamicin (Gentamicin).
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 |
|---|---|---|
| Allogeneic NK（CCT-ANK-11)allogeneic natural killer cells | Drug | A group |
Primary outcome
To evaluate the safety and the efficacy
Time frame: 12 months
To evaluate the safety and objective remission rate of multiple injections of allogeneic natural killer cells (complete remission [CR] + partial remission [PR])
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic NK（CCT-ANK-11) in people with Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer), run by Beijing Kejing Biotechnology Co., Ltd..
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 16 inclusion and 8 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: withdrawn, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and the efficacy (time frame: 12 months). 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 16 Apr 2024.