Experimental cell therapy takes aim at Hard-to-Treat pancreatic cancer
NCT ID NCT05438667
First seen Jun 25, 2026 · Last updated Sep 02, 2026 · Updated 3 times
Summary
This early-phase trial tests a personalized cell therapy called TCR-T cells, engineered to recognize and attack cancer cells with a specific KRAS mutation. Up to 18 adults with advanced pancreatic cancer who have exhausted standard treatments will receive a single infusion of these cells after a short chemotherapy prep. The study primarily checks safety and whether the tumors shrink, while also measuring how long the cells last in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KRAS mutant antigen specific TCR-T cells
- What this could lead to
- If successful, this could point toward a new treatment option for advanced pancreatic cancer that has stopped responding to standard therapies.
- What could go wrong
- This is a very early, small trial (18 participants) focused on safety. The therapy may not shrink tumors or could cause serious side effects like cytokine release syndrome.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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1 person
The number who actually took part.
- Started
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Jun 2023
- Finished
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Jun 2026
- 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 years and older
- 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 greater than 18 years old; 2. Subjects with advanced solid tumors confirmed by histology/cytology who have failed standard treatment, are intolerant to standard treatment, or for whom no standard treatment exists. . Non-small cell lung cancer: Recurrent/metastatic non-small cell lung cancer previously treated with platinum-based chemotherapy and/or immunotherapy and/or anti-angiogenic therapy; ii. Pancreatic cancer: Recurrent/metastatic pancreatic cancer that has failed at least one prior systemic therapy; iii. Colorectal cancer: Recurrent/metastatic colorectal cancer that has failed at least two prior systemic therapies (including oxaliplatin, irinotecan, fluoropyrimidine-based agents, anti-angiogenic drugs, etc.); iiii. Other tumors: Other advanced solid tumors that have failed standard treatment, are intolerant to standard treatment, or for which no standard treatment exists; 3. Previous tissue pathology or peripheral blood testing confirmed the presence of KRAS G12V or G12D mutations with matching HLA subtypes; 4. Expected survival duration of more than 3 months; 5. Eastern Cooperative Oncology Group( ECOG )score ≤2; 6. All participants voluntarily participate in this study and sign an informed consent. And the subjects have good compliance and can cooperate with investigators follow-up study. 7. Patients at least have had at least one measurable lesion as defined by RECIST v1.1 criteria; 8. Female participants can not be pregnant or lactating and their serum or urine human chorionic gonadotropin tests must be negative within 72 hours prior to study enrollment;All subjects must be using a medically accepted means of contraception ( (e.g., oral contraceptives, intrauterine device) during the course of this study and for at least 3 months after completion of study therapy. 9. Organ function and bone marrow reserve are in good condition, and the following requirements must be met: 1)Absolute neutrophil count≥1.5×10⁹/L, Absolute lymphocyte count ≥0.5×10⁹/L;2)Platelet count≥50×10⁹/L;3)Hemoglobin≥90g/L;4)Bilirubin \< 1.5 times upper limit of normal(Bile duct obstruction due to tumor compression were excluded);5)Serum creatinine ≤ 1.5 times the upper limit of normal range or creatinine clearance ≥ 60 mL/min.6)Serum alanine aminotransferase or aspartate aminotransferase is \< 2.5 times the upper limit of the normal value (ULN) (if patients with liver metastasis, ≤5 times the ULN).7)Coagulation function normalised:INR≤1.5,PTT\<1.2 times the upper limit of normal(Tumor - related anticoagulant therapy was excluded). Exclusion Criteria: 1. Intracranial metastasis or Patients with moderate or severe hydrothorax need drain placement to relieve symptoms. 2. Active pulmonary tuberculosis 3. Human immunodeficiency virus (HIV) positive; 4. Active Hepatitis B or Hepatitis C infection; 5. Pregnant women and lactating females; 6. Previous or concurrent history of other malignant tumors. Exceptions include curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy; 7. Patients with central nervous metastases; 8. Serious, uncontrolled comorbidities that may affect protocol compliance or interfere with interpretation of results,or any serious medical condition that may affect the safety of the subjects ; 9. History of clinically significant respiratory diseases or other respiratory diseases that seriously affect Pulmonary function; 10. Any active autoimmune disease,any condition requiring steroid hormones or immunosuppressive therapy( including but not limited to systemic lupus erythematosus, sjogren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc., require \> 10 mg/D of prednisone or equivalent hormone) 11. A history of organ transplantation; 12. A history of myocardial infarction and severe arrhythmia within six months;Ineligible also includes uncontrolled hypertension, coronary heart disease, stroke, liver cirrhosis, nephritis and other serious complications; 13. Those who have a history of psychotropic drug abuse and cannot quit or have a history of psychiatric impairment; 14. Participants with an allergic constitution, known sensitivity to human serum albumin, cyclophosphamide, fludarabine and interleukin 2; 15. Those with bleeding or thromboembolic tendency:bleeding symptoms of clinical significance or a clear tendency to bleeding within 2 weeks prior to entering the study. And those with hereditary or acquired bleeding and thrombotic tendencies; serious arterial/venous thromboembolic events occurred in the previous 6 months; 16. Other severe, acute or chronic medical or mental illnesses that in the investigator's judgement will might be increase the risk associated with the patient's participation in the study or interfere with interpretation of research results.
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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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Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000, China
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