PD-1 AntibodyPhase 2NCT05461235
Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma
A Phase 2 study testing Pembrolizumab, Nivolumab and Sintilimab in people with PD-1 Antibody and DC-Cell, run by China Medical University, China.
Trial summary
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PD-1 Antibody, DC-Cell, NK-Cell
- What is being tested?
- Pembrolizumab, Nivolumab and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 1 Dec 2025
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -1. age: 18-70 years, of either sex 2. pathologically confirmed locally advanced or metastatic gastrointestinal tumour (stage III or IV according to AJCC 8th edition staging) with at least one measurable lesion (meeting RECIST 1.1 criteria) 3. ECOG PS: 0-1 points 4. have adequate organ and bone marrow function, i.e. meet the following criteria.
- Routine blood test criteria to be met.
- HB ≥ 90g/L.
- ANC ≥1.5×109/L.
- PLT ≥90 x 109/L.
- Absolute value of lymphocytes + monocytes >2.0*10^9/L.
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- Biochemical tests are required to meet the following criteria.
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- ALT and AST ≤ 2.5ULN.
- serum Cr ≤ 1 ULN and endogenous creatinine clearance > 60 ml/min (Cockcroft-Gault formula).
- 5. international normalised ratio (INR) ≤ 1.5 and partial thromboplastin time (PPT or APTT) ≤ 1.5 ULN within 7 days prior to enrolment 6. expected survival of ≥ 3 months. 7. signed informed consent form (ICF) prior to study enrolment. 8 Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrolment and have a negative result. Female patients of childbearing age or male patients whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 6 months after the last dose.
Who cannot join
- 1. known hypersensitivity to any of the components of the anti-PD-1 antibody formulation; or previous severe allergic reactions to other monoclonal antibodies.
- 2. diagnosis of other malignancies, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radically resected carcinoma in situ, within 5 years prior to the first dose 3. Subjects who have been treated with an antitumour vaccine or other antitumour agents with immunostimulatory effects (interferon, interleukin, thymidine, immune cell therapy, etc.) within 1 month prior to the first dose.
- 4. CNS metastases with symptoms. Subjects may be enrolled in the study if their CNS metastases have been treated, e.g., clinical stability (MRI detection) has been maintained for at least 4 weeks, and the subject's clinical symptoms, such as neurological symptoms, are able to return to baseline levels at least 2 weeks prior to the first dose (except for residual signs or symptoms related to CNS treatment). In addition, subjects receiving stable or tapered doses of ≤10 mg/day of prednisone (or equivalent) for at least 2 weeks for clinical symptoms associated with treatment with corticosteroids are not eligible for enrollment in the study, otherwise they cannot be enrolled.
- 5. Acute or chronic active hepatitis B (defined as positive HBsAg for hepatitis B virus surface antigen at screening) or hepatitis C infection. Patients with previous hepatitis B virus (HBV) infection or cured HBV infection (defined as hepatitis B core (HBc) antibody positive and HBsAg negative) who are negative for HBV DNA only may be enrolled in this study. HBV DNA testing must be performed on this group of patients prior to enrolment. Patients who are positive for hepatitis C virus (HCV) antibodies and negative for HCV RNA only by polymerase chain reaction may be enrolled in the study. Patients who are antigen-positive but have DNA/RNA copy numbers within the permissible range should be considered for antiviral treatment if enrolled in this study and DNA/RNA levels should be monitored in real time for the duration of the study.
- 6. previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases.
- 7. active tuberculosis (TB), on anti-TB treatment or who have received anti-TB treatment within 1 year prior to the first dose 8. Human immunodeficiency virus (HIV) infected (HIV-positive), known syphilis infection 9. Patients who are considered to be at high medical risk due to severe, uncontrollable disease, non-metastatic systemic disease or having an active, uncontrollable infection. Some examples include, but not all, uncontrolled ventricular arrhythmias, recent (within 3 months) myocardial infarction, uncontrollable grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, HRCT suggestive of extensive bilateral interstitial lung disease or any mental illness that may prevent informed consent from being obtained 10. active autoimmune disease requiring systemic therapy (e.g. use of disease-relieving drugs, corticosteroids or immunosuppressants) that occurred within 2 years prior to the first dose Alternative therapies (e.g. thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are permitted Known history of primary immunodeficiency. Patients with positive autoimmune antibodies only need to confirm the presence of autoimmune disease at the discretion of the investigator.
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- 11. Use of immunosuppressive drugs within 4 weeks prior to first dose, excluding topical glucocorticoids by nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (i.e. not more than 10 mg/day prednisone or equivalent doses of other glucocorticoids), temporary use of glucocorticoids for the treatment of symptoms of dyspnea in conditions such as asthma, chronic obstructive pulmonary disease is permitted.
- 12. exclude subjects who have undergone major surgical procedures within 4 weeks prior to first dose, non-thoracic radiation therapy >30 Gy within 4 weeks prior to first dose, chest radiation >30 Gy within 24 weeks prior to first dose, and palliative radiation <30 Gy within 2 weeks prior to first dose who have not recovered from the toxicity and/or complications of these interventions to NCI-CTC AE ≤1 degree (except alopecia and fatigue excluded) in subjects. Palliative radiotherapy for symptom control is permitted and must be completed at least 2 weeks prior to the start of treatment with the study drug and no additional radiotherapy is planned for the same lesion. For patients who have received radiotherapy prior to 2 weeks prior to the first dose, all of the following conditions must be met for enrolment: absence of any current radiotherapy-related toxic effects, no need for glucocorticoids, exclusion of radiation pneumonia, radiation hepatitis, radiation enteritis, etc.
- 13. Pregnant or breastfeeding women. 14. Participated in a clinical trial of another drug within four weeks. 15. Not considered suitable for inclusion by the investigator. Exclude subjects with a history or current evidence of any disease, treatment or laboratory abnormality that may confound the results of the study, interfere with the subject's participation in the study procedures or is not in the best interest of the subject's participation in the study.
Trial locations and contacts
No sites are listed yet.
Ling Xu, PhD contact
About this study
Official title: A Prospective, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma.
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.
Read the detailed description
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.
This project aims to enhance the anti-tumour activity of DC/NK cells in combination with anti-PD-1 antibodies, and ultimately activate the patient's own immune function to improve the quality of life and survival time of tumour patients, and provide objective evidence for the widespread use of targeted immune cell therapy in the clinical setting.
- Conditions
- PD-1 Antibody, DC-Cell, NK-Cell, Gastrointestinal Tumours
- Being tested
- Pembrolizumab, Nivolumab, Sintilimab, Toripalimab, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
2mg/kg or 200mg,iv,q3w
NivolumabDrug
Also called Opdivo
3mg/kg or 240mg,iv,q2w
SintilimabDrug
Also called Daboshu
200mg,iv,q3w
ToripalimabDrug
Also called Tuoyi
3mg/kg or 240mg,iv,q2w
CamrelizumabDrug
Also called Airuika
200mg,iv,q2w or q3w;3mg/kg,iv,q3w
TislelizumabDrug
Also called Baizean
200mg,iv,q3w
NK-Cell or DC-CellBiological
50ml of peripheral blood was collected 1 day before the dosing cycle for in vitro isolation and amplification of DC and NK cells; the first transfusion of DC and NK cells (not less than 1x10^6 cells/Kg) was completed on day 14.
| Study group | Role | What they receive |
|---|---|---|
| Anti-PD-1 antibody combined with autologous DC and NK cells | Experimental | Anti-PD-1 antibodies (one of six options)
1. Pembrolizumab: 2 mg/kg or 200 mg by intravenous infusion every 3 weeks
2. Nivolumab:3 mg/kg or 240 mg by intravenous infusion every 2 weeks
3. Sintilimab: 200 mg by intravenous infusion every 3 weeks
4. Toripalimab: 3 mg/kg or 240 mg by intravenous infusion every 2 weeks
5. Camrelizumab: 200 mg by intravenous infusion every 2 or 3 weeks, or 3 mg/kg by intravenous infusion every 3 weeks
6. Tislelilzumab: 200mg by intravenous infusion every 3 weeks. DC, NK cells. 50ml of peripheral blood is collected 1 day before the dosing cycle for in vitro isolation and expansion of DC and NK cells; the first infusion of DC and NK cells (not less than 1x10^6 cells/Kg) is completed on day 14. Receives: Drug: Pembrolizumab; Drug: Nivolumab; Drug: Sintilimab; Drug: Toripalimab; Drug: Camrelizumab; Drug: Tislelizumab; Biological: NK-Cell or DC-Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
Measured: one year
Secondary outcomes (3)
Objective Response Rate (ORR)
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Measured: one year
Disease Control Rate (DCR)
Determined using RECIST v1.1 criteria.
Measured: one year
Overall Survival (OS)
Duration from the date of initial treatment to the date of death due to any cause.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Jul 2022 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PD-1 AntibodyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunpeng Liu, China Medical University, China
- Investigators
- Yunpeng Liu, PhD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461235
- Sponsor's protocol ID
- COMBINE
- Status last verified
- Jul 2022
- First submitted
- 14 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma.
- ClinicalTrials.gov ID
- NCT05461235
- Acronym / sponsor ID
- COMBINE
- Conditions
- PD-1 Antibody, DC-Cell, NK-Cell, Gastrointestinal Tumours
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Jul 2022 (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.
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.
Detailed description
This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma.
This project aims to enhance the anti-tumour activity of DC/NK cells in combination with anti-PD-1 antibodies, and ultimately activate the patient's own immune function to improve the quality of life and survival time of tumour patients, and provide objective evidence for the widespread use of targeted immune cell therapy in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Anti-PD-1 antibody combined with autologous DC and NK cells | Experimental | Drug: Pembrolizumab, Drug: Nivolumab, Drug: Sintilimab, Drug: Toripalimab, Drug: Camrelizumab, Drug: Tislelizumab, Biological: NK-Cell or DC-CellAnti-PD-1 antibodies (one of six options) 1. Pembrolizumab: 2 mg/kg or 200 mg by intravenous infusion every 3 weeks 2. Nivolumab:3 mg/kg or 240 mg by intravenous infusion every 2 weeks 3. Sintilimab: 200 mg by intravenous infusion every 3 weeks 4. Toripalimab: 3 mg/kg or 240 mg by intravenous infusion every 2 weeks 5. Camrelizumab: 200 mg by intravenous infusion every 2 or 3 weeks, or 3 mg/kg by intravenous infusion every 3 weeks 6. Tislelilzumab: 200mg by intravenous infusion every 3 weeks. DC, NK cells. 50ml of peripheral blood is collected 1 day before the dosing cycle for in vitro isolation and expansion of DC and NK cells; the first infusion of DC and NK cells (not less than 1x10^6 cells/Kg) is completed on day 14. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -1. age: 18-70 years, of either sex 2. pathologically confirmed locally advanced or metastatic gastrointestinal tumour (stage III or IV according to AJCC 8th edition staging) with at least one measurable lesion (meeting RECIST 1.1 criteria) 3. ECOG PS: 0-1 points 4. have adequate organ and bone marrow function, i.e. meet the following criteria.
- Routine blood test criteria to be met.
- Biochemical tests are required to meet the following criteria.
- 5. international normalised ratio (INR) ≤ 1.5 and partial thromboplastin time (PPT or APTT) ≤ 1.5 ULN within 7 days prior to enrolment 6. expected survival of ≥ 3 months. 7. signed informed consent form (ICF) prior to study enrolment. 8 Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrolment and have a negative result. Female patients of childbearing age or male patients whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 6 months after the last dose.
Key exclusion criteria (9 listed)
- 2. diagnosis of other malignancies, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or radically resected carcinoma in situ, within 5 years prior to the first dose 3. Subjects who have been treated with an antitumour vaccine or other antitumour agents with immunostimulatory effects (interferon, interleukin, thymidine, immune cell therapy, etc.) within 1 month prior to the first dose.
- 4. CNS metastases with symptoms. Subjects may be enrolled in the study if their CNS metastases have been treated, e.g., clinical stability (MRI detection) has been maintained for at least 4 weeks, and the subject's clinical symptoms, such as neurological symptoms, are able to return to baseline levels at least 2 weeks prior to the first dose (except for residual signs or symptoms related to CNS treatment). In addition, subjects receiving stable or tapered doses of ≤10 mg/day of prednisone (or equivalent) for at least 2 weeks for clinical symptoms associated with treatment with corticosteroids are not eligible for enrollment in the study, otherwise they cannot be enrolled.
- 5. Acute or chronic active hepatitis B (defined as positive HBsAg for hepatitis B virus surface antigen at screening) or hepatitis C infection. Patients with previous hepatitis B virus (HBV) infection or cured HBV infection (defined as hepatitis B core (HBc) antibody positive and HBsAg negative) who are negative for HBV DNA only may be enrolled in this study. HBV DNA testing must be performed on this group of patients prior to enrolment. Patients who are positive for hepatitis C virus (HCV) antibodies and negative for HCV RNA only by polymerase chain reaction may be enrolled in the study. Patients who are antigen-positive but have DNA/RNA copy numbers within the permissible range should be considered for antiviral treatment if enrolled in this study and DNA/RNA levels should be monitored in real time for the duration of the study.
- 6. previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases.
- 7. active tuberculosis (TB), on anti-TB treatment or who have received anti-TB treatment within 1 year prior to the first dose 8. Human immunodeficiency virus (HIV) infected (HIV-positive), known syphilis infection 9. Patients who are considered to be at high medical risk due to severe, uncontrollable disease, non-metastatic systemic disease or having an active, uncontrollable infection. Some examples include, but not all, uncontrolled ventricular arrhythmias, recent (within 3 months) myocardial infarction, uncontrollable grand mal seizures, unstable spinal cord compression, superior vena cava syndrome, HRCT suggestive of extensive bilateral interstitial lung disease or any mental illness that may prevent informed consent from being obtained 10. active autoimmune disease requiring systemic therapy (e.g. use of disease-relieving drugs, corticosteroids or immunosuppressants) that occurred within 2 years prior to the first dose Alternative therapies (e.g. thyroxine, insulin or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) are permitted Known history of primary immunodeficiency. Patients with positive autoimmune antibodies only need to confirm the presence of autoimmune disease at the discretion of the investigator.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda2mg/kg or 200mg,iv,q3w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| NivolumabAlso: Opdivo3mg/kg or 240mg,iv,q2w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| SintilimabAlso: Daboshu200mg,iv,q3w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| ToripalimabAlso: Tuoyi3mg/kg or 240mg,iv,q2w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| CamrelizumabAlso: Airuika200mg,iv,q2w or q3w;3mg/kg,iv,q3w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| TislelizumabAlso: Baizean200mg,iv,q3w | Drug | Anti-PD-1 antibody combined with autologous DC and NK cells |
| NK-Cell or DC-Cell50ml of peripheral blood was collected 1 day before the dosing cycle for in vitro isolation and amplification of DC and NK cells; the first transfusion of DC and NK cells (not less than 1x10^6 cells/Kg) was completed on day 14. | Biological | Anti-PD-1 antibody combined with autologous DC and NK cells |
Primary outcome
Progression-free Survival (PFS)
Time frame: one year
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year
Overall Survival (OS)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- 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.
Ling Xu, PhD contact
Yunpeng Liu, PhD principal investigator
First Hospital of China Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Nivolumab and Sintilimab in people with PD-1 Antibody and DC-Cell, run by China Medical University, 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 11 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 Jul 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Liu, PhD (86-24-83282312, cmu_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: one year). 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 18 Jul 2022.