Advanced Solid TumorsEarly Phase 1NCT07504445
Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors
A Early Phase 1 study testing CAR-DC treatment in people with Advanced Solid Tumors, run by Peking University Shenzhen Hospital at 1 site in China.
Trial summary
This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) … Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- CAR-DC treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 3 Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70, regardless of gender;
- Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver cancer, colorectal cancer, gastric cancer, etc; Note: Advanced solid tumors refer to locally advanced (stage III patients) and metastatic advanced (stage IV patients) TNM staging by the American Cancer Society (AJCC).
- Immunohistochemical analysis of pathological tissue approves positive expression for one of the following antigens, including EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3 and CEA, with expression intensity ≥ 2+;
- Failed response to standard treatment or unwilling/intolerant to all standard treatment regimens;
- Imaging indicates measurable tumor lesions;
- ECOG PS score: 0-2;
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- Expected survival time is greater than 3 months;
- Maintaining good organ function and bone marrow reserve capacity:
- Bone marrow: Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L, platelet count ≥ 50 × 10^9/L, hemoglobin ≥ 80 g/L, and no blood transfusion or biological regulator treatments (such as granulocyte colony-stimulating factor, red blood cell growth factor, etc.) within 14 days prior to screening;
- Kidney: creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL/min (according to the Cockcroft-Gault formula); Urine output>10 mL/h within 16-24 hours;
- Coagulation: International Normalized Ratio (INR) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (excluding those receiving therapeutic anticoagulants);
- Other: Blood oxygen saturation ≥ 90%, negative fecal occult blood test, etc.
- The patient is willing to enroll and signs a written informed consent form, and is able to undergo diagnosis, treatment, and visits according to the protocol.
Who cannot join
- Pregnant and lactating women; (The pregnancy test results are included in the CRF)
- The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;
- Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;
- Serious heart diseases such as arrhythmia;
- Autoimmune diseases;
- Active bacterial, fungal, and other infections;
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- Infectious diseases: such as HIV, syphilis, tuberculosis, viral hepatitis and other diseases;
- Patients are receiving medications such as glucocorticoids, thrombolytic drugs, and antipsychotic drugs;
- Patients are believed not suitable for this clinical trial for other reasons by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).
Read the detailed description
Dendritic cell (DC) plays a vital role in T cell priming and anti-tumor immune activation. A novel kind of engineered DC, chimeric antigen receptor-dendritic cell (CAR-DC) can reverse the immune suppression in tumor-microenvironment (TME) to enhance anti-tumor therapy. This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of CAR-DC in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC) , glypican-3 (GPC3) AND carcinoembryonic antigen (CEA). A total number of 10 patients will receive two rounds of intravenous infusions of 30 million CAR-DC at an interval of 14 days and receive follow-up visits after the second round of infusion up to 1 or 2 years.
- Conditions
- Advanced Solid Tumors
- Being tested
- CAR-DC treatment
- Keywords
- CAR-DC, Advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-DC treatmentBiological
The patients will receive intravenous injection (iv) of 30 million CAR-DC for two rounds at an interval of 14 days.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | The patients will be treated with CAR-DC infusion. Receives: Biological: CAR-DC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the objective response rate (ORR) of CAR-DC therapy
The ORR is evaluated according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST1.1) .
Measured: 2 years
To evaluate the disease control rate (DCR) of CAR-DC therapy
The DCR is evaluated according to RECIST1.1 criteria.
Measured: 2 years
The quality of life assessment of CAR-DC therapy
The quality of life is evaluated according to the Eastern Cooperative Oncology Group (ECOG).
Measured: 2 years
Secondary outcomes (3)
To evaluate the cytokine release syndrome (CRS) of CAR-DC therapy
The CRS is evaluated according to National Cancer Institute - the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (NCI CTCAE5.0).
Measured: 2 years
To evaluate the neurotoxicity of CAR-DC therapy
Neurotoxicity is evaluated according to NCI CTCAE5.0
Measured: 2 years
To evaluate the survival time of CAR-DC in patient peripheral blood
The survival time of CAR-DC in patient peripheral blood is analysed by flow cytometry of patient blood samples.
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 posted31 Mar 2026
- Study start10 Jun 2026 (estimated)
- Primary completion3 Apr 2028 (estimated)
- Study completion3 Apr 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 TumorsStudies 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
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junhui Chen, Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504445
- Sponsor's protocol ID
- 2024-164 (Research) -02
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07504445
- Acronym / sponsor ID
- 2024-164 (Research) -02
- Conditions
- Advanced Solid Tumors
- Keywords
- CAR-DC, Advanced solid tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 3 Apr 2028 (estimated)
- Study completion
- 3 Apr 2028 (estimated)
- First posted
- 31 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 a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).
Detailed description
Dendritic cell (DC) plays a vital role in T cell priming and anti-tumor immune activation. A novel kind of engineered DC, chimeric antigen receptor-dendritic cell (CAR-DC) can reverse the immune suppression in tumor-microenvironment (TME) to enhance anti-tumor therapy. This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of CAR-DC in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC) , glypican-3 (GPC3) AND carcinoembryonic antigen (CEA). A total number of 10 patients will receive two rounds of intravenous infusions of 30 million CAR-DC at an interval of 14 days and receive follow-up visits after the second round of infusion up to 1 or 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: CAR-DC treatmentThe patients will be treated with CAR-DC infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18-70, regardless of gender;
- Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver cancer, colorectal cancer, gastric cancer, etc; Note: Advanced solid tumors refer to locally advanced (stage III patients) and metastatic advanced (stage IV patients) TNM staging by the American Cancer Society (AJCC).
- Immunohistochemical analysis of pathological tissue approves positive expression for one of the following antigens, including EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3 and CEA, with expression intensity ≥ 2+;
- Failed response to standard treatment or unwilling/intolerant to all standard treatment regimens;
- Imaging indicates measurable tumor lesions;
Key exclusion criteria (9 listed)
- Pregnant and lactating women; (The pregnancy test results are included in the CRF)
- The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;
- Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;
- Serious heart diseases such as arrhythmia;
- Autoimmune diseases;
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 |
|---|---|---|
| CAR-DC treatmentThe patients will receive intravenous injection (iv) of 30 million CAR-DC for two rounds at an interval of 14 days. | Biological | treatment |
Primary outcome
To evaluate the objective response rate (ORR) of CAR-DC therapy
Time frame: 2 years
The ORR is evaluated according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST1.1) .
To evaluate the disease control rate (DCR) of CAR-DC therapy
Time frame: 2 years
The DCR is evaluated according to RECIST1.1 criteria.
The quality of life assessment of CAR-DC therapy
Time frame: 2 years
The quality of life is evaluated according to the Eastern Cooperative Oncology Group (ECOG).
3 secondary outcomes
To evaluate the cytokine release syndrome (CRS) of CAR-DC therapy
Time frame: 2 years
To evaluate the neurotoxicity of CAR-DC therapy
Time frame: 2 years
To evaluate the survival time of CAR-DC in patient peripheral blood
Time frame: 2 years
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 3 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
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 CAR-DC treatment in people with Advanced Solid Tumors, run by Peking University Shenzhen 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 13 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: opening soon, as of the sponsor's last update on 3 Jun 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 Chen Junhui, professor (+86 138 2316 1919, chenjhpush@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the objective response rate (ORR) of CAR-DC therapy (time frame: 2 years). The study lists 3 primary outcomes in all. 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 3 Jun 2026.