A Study to Evaluate the Safety and Tolerance of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies

A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Efficacy of SYHX1903 in Patients With Relapsed/Refractory Hematologic Malignancies

This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.

Inclusion Criteria:

• Diagnosis of relapsed/refractory hematologic malignancies confirmed by the World Health Organization (WHO) criteria.
• Eastern Cooperative Oncology Group (ECOG) score ≤ 1.
• Life expectancy ≥ 3 months.

Exclusion Criteria:

• Pregnant and lactating females.
• Proven hematologic malignancies of the central nervous system.
• Diagnosed acute promyelocytic leukemia (predominantly granulocytic promyelocytes in bone marrow, which are ≥ 30% in NEC).
• History of other malignant tumors within 5 years, except for cured skin basal cell carcinoma, skin squamous cell carcinoma or cervical carcinoma in situ.