OncoMatch

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.

Early Phase 1Recruitingjianming xuNCT05583201Data as of May 2026

Treatment: KD-496This 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 qualify

Extracted 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.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify