Advanced CancerEarly Phase 1NCT03671720
Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden
A Early Phase 1 study testing personalized DC vaccine in people with Advanced Cancer and Metastatic Cancer, run by Capital Medical University at 1 site in China.
Trial summary
The study is to investigate the safety and efficacy of dendritic cells vaccines pulsed with autologous whole tumor cell lysate for treating advanced solid tumor patients with high tumor mutation burden. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer
- What is being tested?
- personalized DC vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2018to 30 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed advanced or metastatic solid tumors.
- Patients must have received previously standard therapy for that malignancy or declined to chemotherapy/radiotherapy.
- Estimated life expectancy > 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Age 18~75 years old
- Next-generation sequencing identified tumor mutation burden higher than 9 Muts/MB in tumor tissue or peripheral blood samples.
Show all 10Show fewer
- Available for the adequate surgical or core-needle biopsy specimens from primary or metastasis lesions to manufacture the DC vaccines.
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Adequate hematologic function, with WBC ≥ 3000/microliter, hemoglobin ≥ 9 g/dL (it is acceptable to have had prior transfusion), platelets ≥ 75,000/microliter; PT-INR <1.5 (unless patient is receiving warfarin in which case PT-INR must be <3), PTT <1.5X ULN
- Adequate renal and hepatic function, with serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL (except for Gilbert's syndrome which will allow bilirubin ≤ 2.0 mg/dL), ALT and AST ≤ 2.5 x upper limit of normal.
Who cannot join
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
- Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
- Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
- Patients on chronic steroid therapy (or other immuno-suppressives, such as azathioprine or cyclosporin A) are excluded on the basis of potential immune suppression. Patients must have had 6 weeks of discontinuation of any steroid therapy (except that used as pre-medication for chemotherapy or contrast-enhanced studies or for acute treatment (<5 days) of intercurrent medical condition such as a gout flare) prior to enrollment.
- Pregnant and nursing women should be excluded from the protocol since this research may have unknown and harmful effects on an unborn child or on young children. If the patient is sexually active, the patient must agree to use a medically acceptable form of birth control while receiving treatment and for a period of 4 months following the last vaccination therapy. It is not known whether the treatment used in this study could affect the sperm and could potentially harm a child that may be fathered while on this study.
- Patients with acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions will be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site
Capital Medical University Cancer Center/Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
About this study
The study is to investigate the safety and efficacy of dendritic cells vaccines pulsed with autologous whole tumor cell lysate for treating advanced solid tumor patients with high tumor mutation burden.
- Conditions
- Advanced Cancer, Metastatic Cancer
- Being tested
- personalized DC vaccine
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized DC vaccineBiological
personalized vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous tumor cells, administered intranodally on day 1,8,15, with a combination of oral cyclophosphamide (50mg) every day except the day of vaccine administrations.Cycles are repeated every 21 days. Treatment is continued until disease progression or exhaustion of vaccine supply, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| personalized vaccine | Experimental | Not described Receives: Biological: personalized DC vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.All toxicities observed within 30 days of last vaccination will be included.
Measured: 12 months
Secondary outcomes (5)
Objective response rate (ORR)
The rate of patients was evaluated as complete response or partial response
Measured: 6 months
Progression-free survival of the participants(PFS)
From starting date of vaccine treatment until date of first documented disease progression or date of death from any cause, whichever comes first
Measured: 24 months
Overall survival of the participants(OS)
From starting date of vaccine treatment until date of death from any cause
Measured: 24 months
The changes in immune-response specific patient-reported outcomes(irPRO)
To assess the irPRO scale ratings prior to and after the cancer immunotherapy
Measured: 24 months
The changes in patient self-reported quality of life
To assess the EORTC QLQ-C30 scale ratings prior to and after the cancer immunotherapy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start11 Sep 2018
- Primary completion30 Dec 2021
- Study completion30 Dec 2022
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Principal investigator, Jun Ren MD, PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671720
- Sponsor's protocol ID
- TCL DC Vaccine for TMB-High
- Status last verified
- Feb 2024
- First submitted
- 13 Sep 2018
- Last updated
- 7 Feb 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Vaccine Generated by Autologous Dendritic Cells Pulsed With Autologous Whole Tumor Cell Lysate Treat Advanced Solid Tumor Patients With High Tumor Mutation Burden
- ClinicalTrials.gov ID
- NCT03671720
- Acronym / sponsor ID
- TCL DC Vaccine for TMB-High
- Conditions
- Advanced Cancer, Metastatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 14 Sep 2018 (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.
The study is to investigate the safety and efficacy of dendritic cells vaccines pulsed with autologous whole tumor cell lysate for treating advanced solid tumor patients with high tumor mutation burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| personalized vaccine | Experimental | Biological: personalized DC vaccine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed advanced or metastatic solid tumors.
- Patients must have received previously standard therapy for that malignancy or declined to chemotherapy/radiotherapy.
- Estimated life expectancy > 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Age 18~75 years old
Key exclusion criteria (8 listed)
- Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Autoimmune related thyroid disease and vitiligo are permitted.
- Patients with serious intercurrent chronic or acute illness, such as cardiac disease (NYHA class III or IV), hepatic disease, or other illness considered by the Principal Investigator as unwarranted high risk for investigational drug treatment.
- Patients with a medical or psychological impediment to probable compliance with the protocol should be excluded.
- Concurrent (or within the last 5 years) second malignancy other than non melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other carcinoma in situ that has been treated.
- Presence of an active acute or chronic infection including: a urinary tract infection, HIV (as determined by ELISA and confirmed by Western Blot). Patients with HIV are excluded based on immuno-suppression, which may render them unable to respond to the vaccine; patients with chronic hepatitis are excluded because of concern that hepatitis could be exacerbated by the injections.
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 |
|---|---|---|
| personalized DC vaccinepersonalized vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous tumor cells, administered intranodally on day 1,8,15, with a combination of oral cyclophosphamide (50mg) every day except the day of vaccine administrations.Cycles are repeated every 21 days. Treatment is continued until disease progression or exhaustion of vaccine supply, whichever comes first. | Biological | personalized vaccine |
Primary outcome
Treatment-related adverse events
Time frame: 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.All toxicities observed within 30 days of last vaccination will be included.
5 secondary outcomes
Objective response rate (ORR)
Time frame: 6 months
Progression-free survival of the participants(PFS)
Time frame: 24 months
Overall survival of the participants(OS)
Time frame: 24 months
The changes in immune-response specific patient-reported outcomes(irPRO)
Time frame: 24 months
The changes in patient self-reported quality of life
Time frame: 24 months
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 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing personalized DC vaccine in people with Advanced Cancer and Metastatic Cancer, run by Capital Medical University 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 10 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 7 Feb 2024. 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?
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?
Treatment-related adverse events (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 7 Feb 2024.