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

CSPC Pharmaceutical Group

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Multiple Myeloma

Lymphoma

Acute Myeloid Leukemia

Treatments

Drug: SYHX1903

Study type

Interventional

Funder types

Industry

Identifiers

NCT05055791

SYHX1903-CSP-001

Details and patient eligibility

About

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.

Enrollment

312 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.