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 (Jun 2026). This Early Phase 1 trial studies RD133 for cancer.
Treatment: RD133 — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
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.
Frequently asked questions
Is NCT05141253 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy, systematic immunosuppressive therapy, live vaccines disqualifies patients from enrollment.
Does this trial require MSLN?
Yes, MSLN overexpression is a required biomarker for enrollment.
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