Advanced Solid CancersEarly Phase 1NCT07475182
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers
A Early Phase 1 study testing Targeted Activated Dendritic Cells and Targeted CAR-T Cells in people with Advanced Solid Cancers, run by Hainan Cancer Hospital at 1 site in China.
Trial summary
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Cancers
- What is being tested?
- Targeted Activated Dendritic Cells and Targeted CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2025to 6 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and ≤ 75 years, regardless of gender;
- Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm);
- Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);
- Meets the indications for PBMC collection and has no contraindications for cell collection;
- Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);
- ECOG performance status: 0-1;
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- Life expectancy: ≥ 3 months;
- Toxicities from prior chemotherapy or other anti-tumor therapies must have resolved after a washout period (except for residual alopecia), ensuring that all organ functions meet the inclusion criteria;
- Adequate organ function, including:
- Adequate immune function: absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L.
- Adequate hematopoietic function: platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the blood count assessment.
- Adequate liver function: total bilirubin (TBIL) < 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN.
- Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN.
- Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) < 1.5 × ULN, and international normalized ratio (INR) < 1.5.
- Individuals of childbearing potential must agree to use effective contraception during the study;
- Ability to understand and willingness to sign a written informed consent form;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;
- Significant cardiovascular disease, including:
- Documented major cardiovascular events within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or prior angioplasty, stent implantation, or coronary artery bypass grafting;
- Clinically significant QT interval prolongation (QTcF > 470 ms for women or QTcF > 450 ms for men);
- Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);
- Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);
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- History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;
- Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids;
- Poor compliance, as assessed by the investigator;
- Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion;
- Uncontrolled active bacterial or fungal infections;
- Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hainan Cancer Hospital
Haikou, Hainan, 570311
HAIFENG LIN, 13322060949, 13322060949@163.com
About this study
Official title: Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers.
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
- Conditions
- Advanced Solid Cancers
- Being tested
- Targeted Activated Dendritic Cells, Targeted CAR-T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Activated Dendritic CellsBiological
Autologous dendritic cells (DCs) genetically modified to express chimeric antigen receptor (CAR) and activation domain
Targeted CAR-T CellsBiological
Autologous T cells genetically modified to express chimeric antigen receptor (CAR)
| Study group | Role | What they receive |
|---|---|---|
| Targeted Activated Dendritic Cells | Experimental | Not described Receives: Biological: Targeted Activated Dendritic Cells; Biological: Targeted CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
To evaluate adverse events following infusion of targeted activated dendritic cells (DC) and CAR-T cells, with an assessment of the incidence and severity of treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Measured: 2 years post cell infusion
Secondary outcomes (4)
Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Measured: 2 years
Disease Control Rate (DCR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1
Measured: 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause
Measured: 2 years
Changes in the Immune Microenvironment
Assess the changes in the tumor immune microenvironment (TIME) following combined therapy with targeted activated dendritic cells (DCs) and CAR-T cells. The analysis will focus on the composition, density, and functional status of key immune cell populations, including T cell subsets (e.g., CD4+, CD8+), B cells, DC subsets, tumor-associated macrophages (TAMs), and regulatory T cells (Tregs).
Measured: 1 month post cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start6 Dec 2025
- Primary completion6 Dec 2027 (estimated)
- Study completion6 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid CancersStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hainan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frontiergate Biopharm（Hainan） Co., LTD
- Responsible party
- Sponsor
- Investigators
- HAIFENG LIN, Principal investigator, Hainan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475182
- Sponsor's protocol ID
- EC-2025-041-01
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request.The data will be available beginning 6 months and ending 5 years following publication.Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers.
- ClinicalTrials.gov ID
- NCT07475182
- Acronym / sponsor ID
- EC-2025-041-01
- Conditions
- Advanced Solid Cancers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hainan Cancer HospitalUniversity, hospital or other
- Collaborators
- Frontiergate Biopharm（Hainan） Co., LTD
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- 6 Dec 2027 (estimated)
- Study completion
- 6 Jun 2028 (estimated)
- First posted
- 16 Mar 2026 (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 an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Activated Dendritic Cells | Experimental | Biological: Targeted Activated Dendritic Cells, Biological: Targeted CAR-T Cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years and ≤ 75 years, regardless of gender;
- Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm);
- Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);
- Meets the indications for PBMC collection and has no contraindications for cell collection;
- Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);
Key exclusion criteria (12 listed)
- Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;
- Significant cardiovascular disease, including:
- Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);
- Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);
- History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;
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 |
|---|---|---|
| Targeted Activated Dendritic CellsAutologous dendritic cells (DCs) genetically modified to express chimeric antigen receptor (CAR) and activation domain | Biological | Targeted Activated Dendritic Cells |
| Targeted CAR-T CellsAutologous T cells genetically modified to express chimeric antigen receptor (CAR) | Biological | Targeted Activated Dendritic Cells |
Primary outcome
Adverse Events (AEs)
Time frame: 2 years post cell infusion
To evaluate adverse events following infusion of targeted activated dendritic cells (DC) and CAR-T cells, with an assessment of the incidence and severity of treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Changes in the Immune Microenvironment
Time frame: 1 month post cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: Yes. Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request.The data will be available beginning 6 months and ending 5 years following publication.Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.
Related trials for Advanced Solid Cancers
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
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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.
HAIFENG LIN principal investigator
Hainan Cancer Hospital
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 Targeted Activated Dendritic Cells and Targeted CAR-T Cells in people with Advanced Solid Cancers, run by Hainan Cancer Hospital 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 17 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAIFENG LIN (+86-13322060949, 13322060949@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 2 years post cell infusion). 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 Mar 2026.