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OncoMatch/Clinical Trials/NCT05141253

Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors

Is NCT05141253 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies RD133 for cancer.

Early Phase 1RecruitingTongji HospitalNCT05141253Data as of May 2026

Treatment: RD133This study is a single-center exploratory clinical trial. It is estimated that 9-24 subjects will be enrolled. The "3+3" dose escalation design is adopted. The main purpose is to evaluate the safety of RD133 in the treatment of subjects with relapsed or refractory MSLN-positive solid tumors and explore the Recommend phase II dose of RD133 in the treatment of patients with relapsed/refractory MSLN-positive solid tumors.

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Extracted eligibility criteria

Biomarker criteria

Required: MSLN overexpression (>25% positive rate on tumor cell membrane)

>25% Mesothelin positive rate on tumor cell membrane confirmed by prior immunohistochemistry of tumor tissue or freshly punctured tissue

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Cannot have received: gene therapy

Subject who has received gene therapy before enrollment

Cannot have received: systematic immunosuppressive therapy

Exception: except topical drugs

Subject who needs systematic immunosuppressive therapy (except topical drugs) to control autoimmune diseases

Cannot have received: live vaccines

Subject who has been injected with live vaccines within 4 weeks before enrollment

Cannot have received: other interventional clinical research drugs

Subject has received other interventional clinical research drugs within 12 weeks before apheresis

Lab requirements

Blood counts

Neutrophils≥1.0×10^9/L (no G-CSF within 7 days); Platelet count ≥75×10^9/L (no transfusion/TPO within 7 days); Hemoglobin ≥9g/dl (no transfusion within 7 days)

Kidney function

Creatinine clearance rate ≥60 ml/min

Liver function

Bilirubin value ≤1.5×ULN (except bile duct obstruction caused by tumor compression); ALT or AST≤2.5×ULN (with liver involvement ≤5×ULN)

Cardiac function

Echocardiography: ejection fraction ≥50%, without obvious pericardial effusion

subject must have proper organ function and meet all of the following criteria: ... see full criteria

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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