Engineered immune cells target two markers on Hard-to-Treat tumors
NCT ID NCT06134960
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing a new CAR-T cell therapy called KD-496 in people with advanced solid tumors, including gastric and pancreatic cancer, that have not responded to at least two prior treatments. The therapy uses a patient's own T cells, which are genetically modified to recognize two proteins found on these tumors: NKG2DL and CLDN18.2. This Phase 1 trial at a single center in China aims to find out whether the treatment is safe and shows early signs of effectiveness in a small group of 12 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- KD-496, an experimental CAR-T cell therapy made from a patient's own immune cells and engineered to target two tumor markers
- What this could lead to
- If it works, this could point toward a cell therapy option for advanced gastric, pancreatic, and other solid tumors that have run out of standard treatments.
- What could go wrong
- This is a first-in-human Phase 1 study with only 12 participants, so its main job is checking safety, not proving the therapy works. CAR-T therapy can cause serious immune reactions, and the treatment may not shrink these tumors or may help only a few people.
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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2027
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. Subjects fully understand the study and voluntarily sign informed consent; 2. Age 18 to 75 years old (including 75 years old), male and female; 3. Patients diagnosed with advanced solid tumors by histopathology or cytology and failed at least 2 prior lines treatment; preferentially enrolled in gastric cancer, pancreatic cancer, etc. Standard treatment recommendations refer to the latest version of the National Comprehensive Cancer Network (NCCN) guidelines or the Chinese Society of Clinical Oncology (CSCO) guidelines; 4. Immunohistochemistry confirmed that NKG2DL/CLDN18.2 was positive (the sum of NKG2DL and CLDN18.2 positive scores ≥5 according to the principle of positive comprehensive score 0\~12 points).Tissue specimens for IHC testing must be obtained within 1 year prior to registration for screening or, if not available, new tissue samples must be obtained from a recently obtained surgery or diagnostic biopsy; 5. Subjects must have measurable lesions as defined by the RECIST v1.1 standard; 6. ECOG physical status score 0 to 1; 7. Estimated life expectancy ≥ 3 months; 8. Subjects must have adequate peripheral venous access for peripheral blood mononuclear cell (PBMC) collection; 9. Subjects must meet the following conditions prior to screening precondition. If any of the laboratory tests are abnormal, they can be reviewed within 1 week. If the following conditions are still not met, the screening fails: 1)Absolute neutrophil count ≥1.5×10\^9/L, platelets ≥90×10\^9/L, hemoglobin ≥90 g/L (no blood transfusion or erythropoietin within 14 days) 2)Coagulation parameters: INR≤1.5 times upper limit of normal (ULN), APTT≤1.5 ULN; 3)Liver function: total bilirubin ≤1.5 ULN; Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 ULN; 4)Renal function: creatinine ≤1.5 ULN or creatinine clearance ≥60ml/min (Cockcroft and Gault formula); 5)Lung function: SaO2≥92%; 6)Cardiac function: Cardiac ejection fraction (LVEF) ≥50% detected by echocardiography or MUGA 1 month before enrollment; 10.Male and female participants of reproductive age agreed to use an approved contraceptive method (e.g., contraceptive pill, barrier device, IUD) for the duration of the study until at least 12 months after the last dose of infusion and two consecutive PCR tests found no CAR T cells. Exclusion Criteria: 1. Serologically positive for HIV or treponema pallidum, or active hepatitis B (HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive with HCV RNA above the lower limit of assay detection) 2. Any active infection that can't be controlled 3. Patients have autoimmune diseases, have undergone organ transplantation or allogeneic hematopoietic stem cell transplantation, and require long-term systemic glucocorticoid (local use allowed) or other immunosuppressive therapy; 4. History of severe heart disease, including poorly controlled hypertension (SBP \>160mmHg and/or DBP \>90mmHg), and any of the following conditions that have occurred in the past 6 months: prolonged QT interval syndrome, ECG shows QTc interval \>470mSEC, congestive heart failure (New York Heart Association grade ≥ III), cardiac angioplasty and stenting, myocardial infarction, unstable angina, severe arrhythmia, or other heart disease assessed by the investigator as unsuitable for enrollment; 5. Brain metastases with clinical symptoms, except for patients who are stable and asymptomatic lasting at least 14 days after radiotherapy or surgery; 6. Other central nervous system disorders assessed by the investigator to affect the trial: such as seizures, cerebral ischemia/bleeding, dementia, cerebellar diseases, or diseases affecting the central nervous system; 7. Complicated with hematologic malignancies or other primary malignant solid tumors, except for the following cases: 1) patients with cervical cancer or breast cancer in situ with no evidence of disease for more than 3 years after radical treatment; 2) Patients who have successfully received definitive in situ tumor resection without evidence of disease for ≥5 years; 8. Patients with unstable or active peptic ulcer or gastrointestinal bleeding; 9. Received chemotherapy, molecular targeted therapy, interventional therapy, or other antitumor therapy within 3 weeks before apheresis; 10. Patients have received treatment with genetically modified T cells (including CAR-T, TCR-T) or other immune cell therapy previously; 11. Female subjects who are pregnant or breastfeeding; 12. Patients with AEs induced by previous anti-tumor treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia; 13. Received any live vaccine within 2 weeks prior to enrollment; 14. Patients are allergic to precondition drugs (including not limited to fludarabine, cyclophosphamide), allergic to KD-496 injection ingredients (dimethyl sulfoxide, human blood albumin), or have a history of severe allergies (such as anaphylactic shock); 15. Other conditions that investigators considered unsuitable for inclusion;
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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