CarcinomaPhase 1NCT05235607
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
A Phase 1 study testing Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration in people with Carcinoma and Melanoma, run by Sichuan University at 1 site in China.
Trial summary
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Melanoma, Bladder Cancer
- What is being tested?
- Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 2 Dec 2023
- Phase
- 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
- Age:18-75 years
- Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
- Failed in the previous standard therapy;
- ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
- The estimated survival period is ≥3 months;
- Rehabilitate from previous therapy;
- Adequate organ functions;
- Patient's written informed consent;
Who cannot join
- Tumor emergencies;
- Abnormal coagulation function;
- Contagious diseases, such as HIV, HBV, HCV infection;
- Mental disorders;
- Concomitant tumors;
- Immunological co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
- Conditions
- Carcinoma, Melanoma, Bladder Cancer, Colorectal Cancer
- Being tested
- Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration
- Keywords
- Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
- Medical subject headings
- Carcinoma, Melanoma, Urinary Bladder Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administrationBiological
subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Tumor antigen-sensitized vaccine and their sensitized T cells | Experimental | Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times.
Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times. Receives: Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Measured: 3 months after the last administration of cells
Secondary outcomes (1)
Number of participants with Overall survival as assessed by RECIST1.1
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Mar 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
- Investigators
- Ji-Yan Liu, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235607
- Sponsor's protocol ID
- PITTN2021
- Status last verified
- Feb 2022
- First submitted
- 19 Dec 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT05235607
- Acronym / sponsor ID
- PITTN2021
- Conditions
- Carcinoma, Melanoma, Bladder Cancer, Colorectal Cancer
- Keywords
- Melanoma, Bladder Cancer, Colorectal Cancer, tumor neo-antigen DC vaccine, safety, clinical efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 11 Feb 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 single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor antigen-sensitized vaccine and their sensitized T cells | Experimental | Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administrationTumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times. Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age:18-75 years
- Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
- Failed in the previous standard therapy;
- ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
- The estimated survival period is ≥3 months;
Key exclusion criteria (6 listed)
- Tumor emergencies;
- Abnormal coagulation function;
- Contagious diseases, such as HIV, HBV, HCV infection;
- Mental disorders;
- Concomitant tumors;
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 |
|---|---|---|
| Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administrationsubcutaneous administration | Biological | Tumor antigen-sensitized vaccine and their sensitized T cells |
Primary outcome
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Time frame: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
1 secondary outcome
Number of participants with Overall survival as assessed by RECIST1.1
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
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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.
Ji-Yan Liu principal investigator
Sichuan University
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 Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration in people with Carcinoma and Melanoma, run by Sichuan 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 8 inclusion and 6 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 11 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Yan Liu, Prof (028-85422039, liujiyan1972@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0 (time frame: 3 months after the last administration of cells). 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 11 Feb 2022.