OncoMatch/Clinical Trials/NCT05583201
NKG2D/CLDN18.2 CAR-T(KD-496) in the Treatment of Advanced NKG2DL+/CLDN18.2+ Solid Tumors
Is NCT05583201 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies KD-496 for gastric cancer.
Treatment: KD-496 — This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Pancreatic Cancer
Tumor Agnostic
Biomarker criteria
Required: NKG2D overexpression (positive SCORE ≥5 (comprehensive score 0-12))
NKG2DL/CLDN18.2 (according to the positive comprehensive score of 0-12 points, positive SCORE of NKG2DL and CLDN18.2 ≥5) positive confirmed by Immunohistochemistry
Required: CLDN18 overexpression (positive SCORE ≥5 (comprehensive score 0-12))
NKG2DL/CLDN18.2 (according to the positive comprehensive score of 0-12 points, positive SCORE of NKG2DL and CLDN18.2 ≥5) positive confirmed by Immunohistochemistry
Disease stage
Metastatic disease required
Patients diagnosed as advanced solid tumors... Patients must have measurable lesions as defined by RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: gene therapy (CAR-T cell therapy, any T cell therapy)
Patients had received any gene therapy (including CAR-T cell therapy) or any T cell therapy
Cannot have received: cytotoxic treatment
Cytotoxic treatment within 14 days
Cannot have received: small molecule targeted therapy
have received small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter
Cannot have received: monoclonal antibody
Treatment with monoclonal antibodies within 21 days
Cannot have received: immunomodulator therapy
Immunomodulator therapy within 7 days
Cannot have received: radiation therapy
Radiotherapy within 14 days
Lab requirements
Blood counts
Absolute neutrophil count ≥1.5×10^9/L, lymphocyte count ≥0.5×10^9/L, platelet count ≥90×10^9/L, hemoglobin ≥90g/L (no blood transfusion or Erythropoietin within 7 days)
Kidney function
Creatinine ≤1.5ULN or eGFR≥60mL/min (Cockcroft and Gault)
Liver function
Total bilirubin ≤1.5ULN (≤3mg/dL for Gilbert syndrome); ALT or AST ≤3ULN (≤5ULN with liver metastases)
Cardiac function
Cardiac ejection fraction (LVEF) ≥50% by echocardiography or MUGA within 1 month before enrollment
Eligible organ and bone marrow functions defined as follows: ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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