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

• Status: Not yet recruiting
• Trial end date: 2026-09-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Criteria

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.