NCT05166070 An Exploratory Clinical Study of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
| NCT ID | NCT05166070 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2024-01-01 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. The subject must personally sign the written informed consent form approved by the ethics committee before the start of the study; 2. ≥18 years of age; 3. Have received at least 2 prior standard treatments, and achieved no response to the last-line treatment; 4. \>25% Mesothelin positive rate on tumor cell membrane confirmed by prior immunohistochemistry of tumor tissue or freshly punctured tissue; 5. Expected survival ≥ 12 weeks; 6. ECOG score ≤ 2; 7. At least one measurable target lesion that meets the RECIST v1.1 standard; 8. Female or male subjects with fertility should agree to practice an effective method of contraception from the day of signing the ICF until 365 days after the infusion. Effective method of contraception is defined as: abstinence or contraceptive methods with an annual failure rate of \<1% specified in the plan. ； 9. Before being enrolled in the group, the subject must have proper organ function and meet all of the following criteria: 9.1 T