A Phase I Study of Euthare-155008(ETH-155008) in AML and NHL Patients

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShengke Pharmaceuticals (Jiangsu) Limited, China

About this trial

This Trial is an open-label, multicenter trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ETH-155008 in subjects with AML and NHL who previously received standard treatment or are ineligible for standard treatment options.

Eligibility criteria

Qualifiers

Be at least 18 years of age and < 80 years old.

Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures, and can communicated with investigators and are willing to comply with the protocol.

Has histologically or cytologically confirmed relapsed and/or refractory acute myelocytic leukemia(AML) or non-Hodgkin's lymphoma(NHL) with no available standard therapy or is not a candidate for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with ETH-155008 may be beneficial. In addition, the following disease-specific criteria outlined below must be met.

For all indolent NHL (Follicular Lymphoma[FL], Marginal Zone Lymphoma[MZL] and Waldenström Macroglobulinemia[WM]), previously treated with at least 2 prior lines of systemic therapy with at least 1 line being an anti-cluster of differentiation antigen 20(anti-CD20) antibody-containing combination regimen. For chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), prior treatment with at least 2 lines of systemic therapy, including Bruton's tyrosine kinase(BTK) inhibitors or B-cell lymphoma-2(BCL-2) inhibitors, is required.

Disqualifiers

Acute promyelocytic leukemia, acute mixed phenotypic leukemia, acute myeloid leukemia with Philadelphia chromosome (Ph chromosome) positive.

AML with myeloid sarcoma.

The central nervous system (CNS) is known to be involved.

Previous solid organ transplantation.

Trial design

Treatments tested in this trial

  • ETH-155008

Treatment groups

60 Participants
are divided into 1 treatment group