Experimental vaccine trains immune system to fight Hard-to-Treat cancers
NCT ID NCT05631899
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a personalized vaccine made from a patient's own immune cells, designed to target specific cancer markers (EphA2 and KRAS mutations). The vaccine is given along with chemotherapy and two immunotherapy drugs. The study includes 9 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety and see if the vaccine can boost the immune system's ability to fight the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- personalized dendritic cell vaccine (KRAS-EphA-2-CAR-DC) combined with chemotherapy and immune checkpoint inhibitors
- What this could lead to
- If successful, this approach could offer a new treatment option for people with advanced solid tumors that have specific genetic markers.
- What could go wrong
- This is a very early, small trial (9 participants) focused on safety. The treatment may not shrink tumors or improve survival, and side effects like cytokine release syndrome are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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9 people
The number who actually took part.
- Started
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Apr 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 (inclusive). 2. ECOG performance status ≤2 and Estimated life expectancy of more than 3 months. 3. 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. 4. 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. 5. At least one measurable lesion at baseline per RECIST version 1.1. 6. 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. 7. 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. 8. Willing to complete all scheduled visits and assessments at the institution administering therapy. 9. Able to read, understand and provide written informed consent. Exclusion Criteria: 1. Having KRAS (G12V or G12D or G12C) germline mutation. 2. 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. 3. Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation. 4. Evidence of active uncontrolled viral, bacterial, or systemic fungal infection. 5. Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). 6. Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV). 7. 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. 8. Major trauma or major surgery within 4 weeks prior to enrollment. 9. Previous treatment involving KRAS mutant (G12V or G12D or G12C) and EphA2. 10. Systemic chemotherapy and other intervene within 2 weeks prior to vaccination. 11. Being participating or withdrew any other trials within 4 weeks. 12. Any serious underlying medical (eg, pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements. 13. Vaccination within 30 days of study enrollment. 14. Pregnant, lactating, or breastfeeding females. 15. Researchers believe that other reasons are not suitable for clinical trials.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Mining Responders' tumors for clues to a universal cancer therapy