Tumor, SolidEarly Phase 1Neoantigen-TNCT06431529
A Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
A Early Phase 1 study testing tumor neoantigen specific T cell in people with Tumor, Solid, run by JIANG LONGWEI at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are: Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor, Solid
- What is being tested?
- tumor neoantigen specific T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2024to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old;
- Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer;
- Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months;
- ECOG: 0-2 points;
- Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment;
- Those who can understand this trial and have signed the informed consent form;
- Able to follow the research protocol and follow-up procedures
Who cannot join
- Those who have received any form of immunotherapy within the past 3 months;
- Those who need to use immunosuppressants;
- Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month;
- Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) );
- White blood cell count <3E9/L, platelet count <80E9/L;
- AST and ALT>3×the upper limit of normal (ULN), total bilirubin>2×ULN, and AST and ALT>6×ULN in patients with liver metastasis;
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- Creatinine clearance <60ml/min;
- Abnormal coagulation function;
- The patient has active bacterial or fungal infection (≥Grade 2 of NCI-CTC, third edition);
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA detection value is >100 IU/mL; hepatitis C virus (HCV) antibody is positive and the peripheral blood hepatitis C Those who are positive for hepatitis virus (HCV) RNA; those who are positive for human immunodeficiency virus (HIV) antibodies; those who are positive for cytomegalovirus (CMV) DNA; those who are positive for syphilis;
- Diseases judged by the researcher to be ineligible for inclusion: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment, uncontrollable coronary artery disease or asthma, and uncontrollable cerebrovascular disease.
- Women who are pregnant or breastfeeding, and women of childbearing age must have a negative pregnancy test within 7 days before enrollment;
- Substance abuse, clinical or psychological or social factors that affect informed consent or research implementation;
- Those who may be allergic to study drugs;
- Participate in other clinical trials one month before registration;
- Patients who cannot undergo mononuclear cell separation or whose peripheral venous access cannot be opened;
- Any uncertain factors that affect patient safety or compliance;
- Other researchers believe that the subject is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Jinling Hospital
Nanjing, Jiangsu, 210002
Jiang Longwei, Master, +86-02580864524, jianglw2005@163.com
Jia Shaochang, MD
About this study
Official title: Exploratory Clinical Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are:
Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer.
To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients.
Read the detailed description
In this open, single-armed study, selected patients with advanced solid tumor confirmed by Histopathology will be received tumor neoantigen specific T cells treatment. First, their tumor specimen will be collected from surgery or puncture，then their PBMC will be separated by blood cell separator. This cells will be cultured and selected in GMP laboratory to make tumor neoantigen specific T cells. The tumor neoantigen specific T cells will be infused intravenous into patients.
- Conditions
- Tumor, Solid
- Being tested
- tumor neoantigen specific T cell
- Keywords
- Solid tumor; T cell; neoantigen
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor neoantigen specific T cellBiological
Isolate the patient's autologous monocytes, induce and culture them into tumor antigen presenting cells in vitro, and then phagocytose tumor tissue cells obtained from biopsy or surgery to present tumor neoantigens to autologous T cells. The final product For tumor neoantigen specific T cells (NeoT).
| Study group | Role | What they receive |
|---|---|---|
| tumor neoantigen specific T cell | Experimental | Tumor neoantigen specific T cells will be infused intravenously into patients. The number of T cells will be more than 1.0E9. Receives: Biological: tumor neoantigen specific T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients
The adverse events and severe adverse events will be evaluated.
Measured: 2 years
Secondary outcomes (1)
Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.
The objective clinical response will be evaluated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start18 Apr 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JIANG LONGWEI
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing University
- Responsible party
- Sponsor-investigator, JIANG LONGWEI, Jinling Hospital, China
- Investigators
- Jia Shaochang, MD, Study director, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431529
- Sponsor's protocol ID
- SWZL20231008
- Acronym
- Neoantigen-T
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 28 May 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 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Tumor Neoantigen-specific T Cells in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06431529
- Acronym / sponsor ID
- Neoantigen-T / SWZL20231008
- Conditions
- Tumor, Solid
- Keywords
- Solid tumor; T cell; neoantigen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- JIANG LONGWEIUniversity, hospital or other
- Collaborators
- Nanjing University
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 May 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.
The goal of this clinical trial is to learn if tumor neoantigen-specific T cells can treat patients with advanced solid tumors. The main questions it aims to answer are:
Evaluate the safety of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer.
To evaluate the effectiveness of intravenous infusion of tumor neoantigen-specific T cells in the treatment of advanced solid tumors such as ovarian cancer, non-small cell lung cancer, and colorectal cancer and to study its immunological properties in patients.
Detailed description
In this open, single-armed study, selected patients with advanced solid tumor confirmed by Histopathology will be received tumor neoantigen specific T cells treatment. First, their tumor specimen will be collected from surgery or puncture，then their PBMC will be separated by blood cell separator. This cells will be cultured and selected in GMP laboratory to make tumor neoantigen specific T cells. The tumor neoantigen specific T cells will be infused intravenous into patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor neoantigen specific T cell | Experimental | Biological: tumor neoantigen specific T cellTumor neoantigen specific T cells will be infused intravenously into patients. The number of T cells will be more than 1.0E9. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old;
- Patients with solid malignant tumors confirmed by histology or cytology such as ovarian cancer, non-small cell lung cancer or colorectal cancer;
- Cancer patients who have failed previous standard treatments or who have refused subsequent chemotherapy and whose expected survival time exceeds 3 months;
- ECOG: 0-2 points;
- Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the experiment;
Key exclusion criteria (18 listed)
- Those who have received any form of immunotherapy within the past 3 months;
- Those who need to use immunosuppressants;
- Those who have received anti-tumor treatment such as tumor chemotherapy, radiotherapy, and secondary and above surgery within the past month;
- Those who have a history of other tumors in the past, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years before enrollment) );
- White blood cell count <3E9/L, platelet count <80E9/L;
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 neoantigen specific T cellIsolate the patient's autologous monocytes, induce and culture them into tumor antigen presenting cells in vitro, and then phagocytose tumor tissue cells obtained from biopsy or surgery to present tumor neoantigens to autologous T cells. The final product For tumor neoantigen specific T cells (NeoT). | Biological | tumor neoantigen specific T cell |
Primary outcome
Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients
Time frame: 2 years
The adverse events and severe adverse events will be evaluated.
1 secondary outcome
Evaluate the efficiency of tumor neoantigen specific T cells in the treatment of advanced solid tumor.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 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.
Jia Shaochang, MD study director
Jinling Hospital, China
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 tumor neoantigen specific T cell in people with Tumor, Solid, run by JIANG LONGWEI 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 7 inclusion and 18 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 28 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Longwei, Master (+86-02580864524, jianglw2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of tumor neoantigen specific T cells in the treatment of advanced tumor patients (time frame: 2 years). 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 28 May 2024.