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OncoMatch/Clinical Trials/NCT05758610

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

Is NCT05758610 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ETH-155008 for nhl, adult.

Phase 1RecruitingShengke Pharmaceuticals (Jiangsu) Limited, ChinaNCT05758610Data as of May 2026

Treatment: ETH-155008This 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: systemic therapy

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

Must have received: systemic therapy

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

Must have received: systemic therapy

prior treatment with at least 2 lines of systemic therapy (including a combination regimen of anti-CD20 antibodies and BTK inhibitors)

Must have received: standard second-line therapy or standard first-line therapy

patients who can tolerate intensive therapy or autologous hematopoietic stem cell transplantation are required to have received standard second-line therapy in the past but have failed or relapsed. If patients cannot tolerate intensive therapy or autologous hematopoietic stem cell transplantation, they must have received standard first-line therapy in the past, but therapy failed or relapsed

Must have received: systemic standard dose of drugs

adequately treated with a systemic standard dose of drugs in the past without remission or recurrence

Cannot have received: CDK4/6 inhibitor

Prior treatment with a cyclin dependent kinase 4 and 6(CDK4/6) ... inhibitor

Cannot have received: Pim inhibitor

Prior treatment with a ... Pim inhibitor

Cannot have received: allogeneic hematopoietic stem cell transplantation

Previously received allogeneic hematopoietic stem cell transplantation

Cannot have received: autologous hematopoietic stem cell transplantation

Exception: within 3 months prior to initial administration of ETH-155008

The patient received autologous hematopoietic stem cell transplantation (HSCT) within 3 months prior to initial administration of ETH-155008

Cannot have received: chemotherapy or targeted therapy

Exception: within 2 weeks (or five half-lives, which is the longer) prior to first dosing treatment

Prior chemotherapy or targeted therapy within 2 weeks(Or five half-lives, which is the longer) prior to first dosing treatment

Cannot have received: investigational anticancer agent or radiotherapy (including investigational vaccines)

Exception: within 4 weeks before the first administration of ETH-155008

treatment with an investigational anticancer agent or radiotherapy (including investigational vaccines) within 4 weeks before the first administration of ETH-155008

Cannot have received: CAR-T cell therapy

Exception: within 12 weeks before the first administration of ETH-155008

Prior chimeric antigen receptor T-Cell(CAR-T) immunotherapy within 12 weeks before the first administration of ETH-155008

Lab requirements

Blood counts

For NHL: Hemoglobin ≥80g/L (≥60g/L if bone marrow invasion); Platelet count ≥75×10^9/L (≥50×10^9/L if bone marrow invasion); ANC ≥1.0×10^9/L (≥0.75×10^9/L if bone marrow invasion). For AML: WBC <25×10^9/L before first administration

Kidney function

Creatinine clearance rate(CCr)≥45 ml/min (Cockcroft-Gault formula)

Liver function

AST, ALT ≤2.5×ULN (≤5×ULN if primary liver invasion); TBIL ≤1.5×ULN (≤3×ULN if primary liver invasion)

Cardiac function

QTcF female >470ms, male >450ms excluded; no recent MI, unstable angina, significant arrhythmias, uncontrolled hypertension, stroke/TIA, VTE within 1 month, CHF NYHA III-IV, pericarditis, myocarditis, endocarditis

Blood biochemical test results must be within the following range: AST, ALT ≤2.5×ULN (≤5×ULN if primary liver invasion); TBIL ≤1.5×ULN (≤3×ULN if primary liver invasion); Creatinine clearance rate(CCr)≥45 ml/min (Cockcroft-Gault formula); Prothrombin time(PT) and activated partial thromboplastin time(aPTT) ≤1.5×ULN. For NHL, hematology laboratory parameters ... For AML, ... WBC <25×10^9/L before first administration. Cardiac: see exclusion criteria 15.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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