Solid Tumor, AdultPhase 1NCT05631899
CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors
A Phase 1 study testing KRAS-EphA-2-CAR-DC, Abraxane and Cyclophosphamide in people with Solid Tumor, Adult and EphA2 Overexpression, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide (KRAS-EphA-2-CAR-DC) in combination with ICIs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor, Adult, EphA2 Overexpression, KRAS G12V
- What is being tested?
- KRAS-EphA-2-CAR-DC, Abraxane and Cyclophosphamide
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2023to 30 Dec 2026
- Phase
- 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 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Local advanced/metastatic solid tumors confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and KRAS mutation (G12V or G12D or G12C) within 6 months prior to screening. The second malignancy is allowed.
- No clinical response to standard frontline therapy, or no standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented. Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB.
- At least one measurable lesion at baseline per RECIST version 1.1.
- Adequate organ function as defined by the following criteria: ANC ≥1000 cells/μL; Platelet count ≥80,000/μL; Hemoglobin ≥8.0 g/dL; Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total serum bilirubin ≤3.0 x ULN); Serum creatinine ≤2 x ULN or creatinine clearance of ≥45 mL/min.
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- Willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide formalin-fixed paraffin-embedded (FFPE) tumor tissue block or freshly cut unstained slides.
- Willing to complete all scheduled visits and assessments at the institution administering therapy.
- Able to read, understand and provide written informed consent.
Who cannot join
- Having KRAS (G12V or G12D or G12C) germline mutation.
- Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV).
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- Patients with history (within the last 5 years) or risk of autoimmune disease who have immunosuppressive medications or immunosuppressive doses of systemic corticosteroids (>10 mg/day prednisone or equivalent) within 28 days prior to enrollment. However, patients who received a short course of corticosteroids (eg, premedication prior to antibody drug) will be eligible for study entry.
- Major trauma or major surgery within 4 weeks prior to enrollment.
- Previous treatment involving KRAS mutant (G12V or G12D or G12C) and EphA2.
- Systemic chemotherapy and other intervene within 2 weeks prior to vaccination.
- Being participating or withdrew any other trials within 4 weeks.
- Any serious underlying medical (eg, pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements.
- Vaccination within 30 days of study enrollment.
- Pregnant, lactating, or breastfeeding females.
- Researchers believe that other reasons are not suitable for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With KRAS Mutant Peptide in Combination With Anti-PD-1 Antibody/Anti-CTLA4 Antibody for Local Advanced/Metastatic Solid Tumors.
This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide (KRAS-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of KRAS-EphA-2-CAR-DC vaccine; detect T cell response against KRAS mutant peptide and tumor neoepitopes after the treatment with KRAS-EphA-2-CAR-DC vaccine and ICIs.
Read the detailed description
Therapeutic cancer vaccines, especially DC-based vaccines, are extensively pursued immune approaches in addition to immune checkpoint blockade antibodies and chimeric antigen receptor T cells. DCs can engulf, process and present tumor antigens to T cells, thereby initiating a potent and tumor-specific immune response. However, clinical outcomes of therapeutic cancer vaccines still remain poor, with objective response rates that rarely exceed ~15%. The maturation and activation of DCs are necessary steps to trigger the antitumor responses. However, it is increasingly clear that tumor-infiltrating dendritic cells (TIDCs) usually have an immature or tolerated phenotype that plays central roles in developing tumor microenvironment (TME). As a consequence, malfunction of TIDCs could suppress the infiltration and function of tumor infiltrating T cells and convert them into immune suppressive regulatory T cells.
In our previous research, we constructed novel CAR-DCs (Chimeric antigen receptor engineered dendritic cells) containing a scFv domain targeting EphA2 antigen, CD8a transmembrane, tandem DC-specific activation domains. The engineered CAR-DCs were activated when contacting with tumor targets in TME, and consequently, augmented the cytotoxicity of antigen specific T cells in immune system humanized solid tumor mouse models. Our design of CAR-DCs provides an effective vaccine strategy for solid tumors. Therefore, we designed an autologous CAR-DC vaccine engineered with anti-EphA2 CAR and KRAS mutant peptide (KRAS-EphA-2-CAR-DC) , which can suppress the growth of tumors expressing the correlated KRAS mutant in animal models. In addition, the combination of the immune checkpoint inhibitors could further reverse immunosuppressive TME and globally activate T cell responses. In this pilot study, we aim to assess the safety, efficacy and immune response of KRAS-EphA-2-CAR-DC combined with anti-PD-1 antibody/anti-CTLA4 antibody in patients with local advanced/metastatic solid tumors.
- Conditions
- Solid Tumor, Adult, EphA2 Overexpression, KRAS G12V, KRAS G12C, KRAS G12D
- Being tested
- KRAS-EphA-2-CAR-DC, Abraxane, Cyclophosphamide, Anti-PD-1 antibody, Anti-CTLA4 Monoclonal Antibody
- Keywords
- Local Advanced/Metastatic
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRAS-EphA-2-CAR-DCBiological
5~10 × 10^6 CAR-DCs per dose will be administered by intravenous injection.
AbraxaneDrug
Also called Abraxane Injectable Product
Intravenous abraxane 125 mg/m^2/day on day-5.
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Intravenous cyclophosphamide 300 mg/m^2/day on day -4.
Anti-PD-1 antibodyDrug
Also called PD-1 blocking antibody
Intravenous anti-PD-1 antibody 200 mg/day.
Anti-CTLA4 Monoclonal AntibodyDrug
Also called Ipilimumab
Intravenous anti-CTLA4 antibody 1 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| KRAS-EphA-2-CAR-DC | Experimental | In the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1.
In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 4 weeks since Week 5 for a total of 6 to 8 doses, then maintenance vaccination is given one dose every 8 weeks, until:
1. Unacceptable toxicity occurred or disease progression; or
2. Reactive T cells are undetected repeatedly after the last vaccine dose; or
3. Vaccine exhaustion. Receives: Biological: KRAS-EphA-2-CAR-DC; Drug: Abraxane; Drug: Cyclophosphamide |
| KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody | Experimental | In the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1.
In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 4 weeks since Week 5 for a total of 6 to 8 doses, then maintenance vaccination is given one dose every 8 weeks.
Anti-PD-1 antibody is administered 2 days after the first dose of KRAS-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 4 weeks afterwards, until:
1. Unacceptable toxicity occurred or disease progression; or
2. Reactive T cells are undetected repeatedly after the last vaccine dose; or
3. Vaccine exhaustion. Receives: Biological: KRAS-EphA-2-CAR-DC; Drug: Abraxane; Drug: Cyclophosphamide; Drug: Anti-PD-1 antibody |
| KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody | Experimental | In the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1.
In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 8 weeks since Week 5.
Anti-PD-1 antibody and anti-CTLA4 antibody are administered 2 days after the first dose of KRAS-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 3 weeks afterwards for four doses, followed by anti-PD-1 antibody once every 3 weeks, until:
1. Unacceptable toxicity occurred or disease progression; or
2. Reactive T cells are undetected repeatedly after the last vaccine dose; or
3. Vaccine exhaustion. Receives: Biological: KRAS-EphA-2-CAR-DC; Drug: Abraxane; Drug: Cyclophosphamide; Drug: Anti-PD-1 antibody; Drug: Anti-CTLA4 Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events (AEs)
Determining the safety profile following the initiation of treatment and grading these toxicities by CTCAE v5.0. AEs such as cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Measured: 2 years
Clinical Response
Clinical response will be determined by RECIST 1.1 and iRECIST criteria. Response rate is the proportion of patients that achieve CR and PR.
Measured: 2 years
Disease Control
Disease control will be determined by RECIST 1.1 and iRECIST criteria. Disease control rate is the proportion of patients that achieve CR, PR and SD.
Measured: 2 years
Immune Response
Immune response will be evaluated by phenotype and functional analysis of vaccine-reactive T cells and Neoantigen-reactive T cells as well as other immune cells in peripheral blood and tumor samples. Response is defined by ≥3 folds increase relative to pre-vaccination.
Measured: Peripheral blood: baseline, weekly before Week 9, prior to each vaccination after Week 9 until last vaccination and 1 year after last vaccine. Tumor tissue: baseline, Week 3, and following timing will be performed according to subject's condition.
Secondary outcomes (6)
Progression Free Survival (PFS)
PFS is defined as the time from KRAS-EphA-2-CAR-DCs infusion to documented disease progression or death.
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from KRAS-EphA-2-CAR-DCs infusion to the date of death.
Measured: 2 years
Time to response (TTR)
TTR is defined as the time from KRAS-EphA-2-CAR-DCs infusion to first assessed CR or PR by investigators and based on the iRECIST criteria.
Measured: 2 years
Duration of response (DOR)
DOR is defined as the time from objective response (OR) until documented tumor progression date among responders.
Measured: 2 years
Number and copy number of KRAS-EphA-2-CAR-DCs
Number and copy number of KRAS-EphA-2-CAR-DCs were assessed by number in peripheral blood and tumor tissue.
Measured: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the day before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
The level of cytokines in serum
The cytokines mainly include IL-1, IL-2, IL-6, IL-8, IL-10, IL-12 (p70), TNF-α
Measured: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the days before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start3 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Yang Xu, Ph.D, Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631899
- Sponsor's protocol ID
- CHN-PLAGH-BT-074
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With KRAS Mutant Peptide in Combination With Anti-PD-1 Antibody/Anti-CTLA4 Antibody for Local Advanced/Metastatic Solid Tumors.
- ClinicalTrials.gov ID
- NCT05631899
- Acronym / sponsor ID
- CHN-PLAGH-BT-074
- Conditions
- Solid Tumor, Adult, EphA2 Overexpression, KRAS G12V, KRAS G12C, KRAS G12D
- Keywords
- Local Advanced/Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Nov 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 is a pilot clinical trial for subjects with local advanced/metastatic solid tumors to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with KRAS mutant peptide (KRAS-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of KRAS-EphA-2-CAR-DC vaccine; detect T cell response against KRAS mutant peptide and tumor neoepitopes after the treatment with KRAS-EphA-2-CAR-DC vaccine and ICIs.
Detailed description
Therapeutic cancer vaccines, especially DC-based vaccines, are extensively pursued immune approaches in addition to immune checkpoint blockade antibodies and chimeric antigen receptor T cells. DCs can engulf, process and present tumor antigens to T cells, thereby initiating a potent and tumor-specific immune response. However, clinical outcomes of therapeutic cancer vaccines still remain poor, with objective response rates that rarely exceed ~15%. The maturation and activation of DCs are necessary steps to trigger the antitumor responses. However, it is increasingly clear that tumor-infiltrating dendritic cells (TIDCs) usually have an immature or tolerated phenotype that plays central roles in developing tumor microenvironment (TME). As a consequence, malfunction of TIDCs could suppress the infiltration and function of tumor infiltrating T cells and convert them into immune suppressive regulatory T cells.
In our previous research, we constructed novel CAR-DCs (Chimeric antigen receptor engineered dendritic cells) containing a scFv domain targeting EphA2 antigen, CD8a transmembrane, tandem DC-specific activation domains. The engineered CAR-DCs were activated when contacting with tumor targets in TME, and consequently, augmented the cytotoxicity of antigen specific T cells in immune system humanized solid tumor mouse models. Our design of CAR-DCs provides an effective vaccine strategy for solid tumors. Therefore, we designed an autologous CAR-DC vaccine engineered with anti-EphA2 CAR and KRAS mutant peptide (KRAS-EphA-2-CAR-DC) , which can suppress the growth of tumors expressing the correlated KRAS mutant in animal models. In addition, the combination of the immune checkpoint inhibitors could further reverse immunosuppressive TME and globally activate T cell responses. In this pilot study, we aim to assess the safety, efficacy and immune response of KRAS-EphA-2-CAR-DC combined with anti-PD-1 antibody/anti-CTLA4 antibody in patients with local advanced/metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KRAS-EphA-2-CAR-DC | Experimental | Biological: KRAS-EphA-2-CAR-DC, Drug: Abraxane, Drug: CyclophosphamideIn the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1. In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 4 weeks since Week 5 for a total of 6 to 8 doses, then maintenance vaccination is given one dose every 8 weeks, until: 1. Unacceptable toxicity occurred or disease progression; or 2. Reactive T cells are undetected repeatedly after the last vaccine dose; or 3. Vaccine exhaustion. |
| KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody | Experimental | Biological: KRAS-EphA-2-CAR-DC, Drug: Abraxane, Drug: Cyclophosphamide, Drug: Anti-PD-1 antibodyIn the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1. In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 4 weeks since Week 5 for a total of 6 to 8 doses, then maintenance vaccination is given one dose every 8 weeks. Anti-PD-1 antibody is administered 2 days after the first dose of KRAS-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 4 weeks afterwards, until: 1. Unacceptable toxicity occurred or disease progression; or 2. Reactive T cells are undetected repeatedly after the last vaccine dose; or 3. Vaccine exhaustion. |
| KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody | Experimental | Biological: KRAS-EphA-2-CAR-DC, Drug: Abraxane, Drug: Cyclophosphamide, Drug: Anti-PD-1 antibody, Drug: Anti-CTLA4 Monoclonal AntibodyIn the priming phase, a conditioning chemotherapy regimen of Abraxane and cyclophosphamide is administered three days before vaccination, and KRAS-EphA-2-CAR-DC vaccine is infused on Day 0 and Day 7 in Week 1. In the boost phase, KRAS-EphA-2-CAR-DC vaccine is infused one dose every 8 weeks since Week 5. Anti-PD-1 antibody and anti-CTLA4 antibody are administered 2 days after the first dose of KRAS-EphA-2-CAR-DC vaccine in the boost phase (Day 3 in Week 5) and every 3 weeks afterwards for four doses, followed by anti-PD-1 antibody once every 3 weeks, until: 1. Unacceptable toxicity occurred or disease progression; or 2. Reactive T cells are undetected repeatedly after the last vaccine dose; or 3. Vaccine exhaustion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 (inclusive).
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months.
- Local advanced/metastatic solid tumors confirmed by histopathology or cytology with documentation of tumor EphA2 positive (≥20%) and KRAS mutation (G12V or G12D or G12C) within 6 months prior to screening. The second malignancy is allowed.
- No clinical response to standard frontline therapy, or no standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented. Previous treatment with anti-PD-1/PD-L1 antibodies or anti-CTLA4 antibody are allowed, regardless of the level of PD-1/PD-L1 expression, dMMR and TMB.
- At least one measurable lesion at baseline per RECIST version 1.1.
Key exclusion criteria (15 listed)
- Having KRAS (G12V or G12D or G12C) germline mutation.
- Active central nervous system disease involvement (but allow patients with prior brain metastases treated at least 4 weeks prior to enrollment that are clinically stable and do not require intervention), or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation.
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
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 |
|---|---|---|
| KRAS-EphA-2-CAR-DC5~10 × 10^6 CAR-DCs per dose will be administered by intravenous injection. | Biological | KRAS-EphA-2-CAR-DC, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody |
| AbraxaneAlso: Abraxane Injectable ProductIntravenous abraxane 125 mg/m^2/day on day-5. | Drug | KRAS-EphA-2-CAR-DC, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody |
| CyclophosphamideAlso: Cyclophosphamide for InjectionIntravenous cyclophosphamide 300 mg/m^2/day on day -4. | Drug | KRAS-EphA-2-CAR-DC, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody |
| Anti-PD-1 antibodyAlso: PD-1 blocking antibodyIntravenous anti-PD-1 antibody 200 mg/day. | Drug | KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody, KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody |
| Anti-CTLA4 Monoclonal AntibodyAlso: IpilimumabIntravenous anti-CTLA4 antibody 1 mg/kg/day | Drug | KRAS-EphA-2-CAR-DC plus anti-PD-1 antibody and anti-CTLA4 antibody |
Primary outcome
Incidence of treatment related adverse events (AEs)
Time frame: 2 years
Determining the safety profile following the initiation of treatment and grading these toxicities by CTCAE v5.0. AEs such as cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
Clinical Response
Time frame: 2 years
Clinical response will be determined by RECIST 1.1 and iRECIST criteria. Response rate is the proportion of patients that achieve CR and PR.
Disease Control
Time frame: 2 years
Disease control will be determined by RECIST 1.1 and iRECIST criteria. Disease control rate is the proportion of patients that achieve CR, PR and SD.
Immune Response
Time frame: Peripheral blood: baseline, weekly before Week 9, prior to each vaccination after Week 9 until last vaccination and 1 year after last vaccine. Tumor tissue: baseline, Week 3, and following timing will be performed according to subject's condition.
Immune response will be evaluated by phenotype and functional analysis of vaccine-reactive T cells and Neoantigen-reactive T cells as well as other immune cells in peripheral blood and tumor samples. Response is defined by ≥3 folds increase relative to pre-vaccination.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Number and copy number of KRAS-EphA-2-CAR-DCs
Time frame: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the day before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
The level of cytokines in serum
Time frame: Peripheral blood samples are collected on days 0, 3, 7, 10, 22, the days before each vaccination until last vaccination and 1 year after last vaccine. Tumor tissues are collected at baseline, the day before Week 5, and after combination.
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 24 Nov 2025.
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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.
Yang Xu, Ph.D study director
Zhejiang 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 KRAS-EphA-2-CAR-DC, Abraxane and Cyclophosphamide in people with Solid Tumor, Adult and EphA2 Overexpression, run by Chinese PLA General 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 9 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. 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?
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?
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?
Incidence of treatment related adverse events (AEs) (time frame: 2 years). The study lists 4 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 24 Nov 2025.