NCT07113925 A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies

Trial Parameters

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Brief Summary

TQB2101 for Injection is an Antibody-Drug Conjugate (ADC) targeting Receptor Tyrosine Kinase Like Orphan Receptor 1 (ROR1).It consists of three main components: a ROR1 monoclonal antibody responsible for selectively recognizing the surface antigen of cancer cells, a small molecule toxin responsible for killing cancer cells, and a linker connecting the antibody and the small molecule toxin. It is intended for clinical use in the treatment of advanced malignant tumors, including advanced malignant hematological tumors.

Eligibility Criteria

Inclusion Criteria: * Subjects voluntarily participate in this study, sign the informed consent form, and demonstrate good compliance. * Age between 18 and 75 years (calculated based on the date of signing the informed consent form). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. * Expected survival \>12 weeks. * Subjects with advanced hematologic malignancies confirmed by cytology/histopathology, who have failed standard treatment or lack effective treatment options. * At least one measurable lesion according to the 2014 Lugano criteria: lymph node lesions with long axis \>15mm or extranodal lesions with long axis \>10mm on CT cross-sectional imaging. * Adequate organ function meeting the following criteria: 1. Hemoglobin (HGB) ≥80g/L 2. Absolute neutrophil count (ANC) ≥1.0×10⁹/L 3. Platelet count (PLT) ≥75×10⁹/L (≥50×10⁹/L if with bone marrow involvement) 4. Total bilirubin (TBIL) ≤1.5×ULN 5. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase

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