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New treatment option for AML (Acute Myelogenous Leukemia
Official title Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07014449
What this study is testing
What is WBC100 QD?
WBC100 QD is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for aml (acute myelogenous leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The main questions it aims to answer are: What is the safety and tolerability profile of WBC100 in R/R AML patients?
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Signed informed consent and compliance with study procedures;
- 2\. Male or female participants aged ≥18 years at the time of consent;
- 3\. Diagnosis of relapsed or refractory acute myeloid leukemia (R/R AML) according to the 2016 World Health Organization (WHO) classification;
- 4\. ECOG PS 0-2;
- 5\. Life expectancy ≥3 months;
You likely can't join if
- 1\. Known hypersensitivity to WBC100 capsules or any of their excipients;
- 2\. Diagnosis of acute promyelocytic leukemia (APL);
- 3\. Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML transformed from myelodysplastic syndromes (MDS) or...
- 4\. people with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT...
- 5\. people who have undergone major surgery, have active ulcers, or have unhealed wounds within 28 days prior to the first dose;
- 6\. Received other investigational drugs or treatments within 28 days prior to the first administration, or are still within the safety follow-up...
See the full eligibility criteria
Who can join
- 1\. Signed informed consent and compliance with study procedures;
- 2\. Male or female participants aged ≥18 years at the time of consent;
- 3\. Diagnosis of relapsed or refractory acute myeloid leukemia (R/R AML) according to the 2016 World Health Organization (WHO) classification;
- 4\. ECOG PS 0-2;
- 5\. Life expectancy ≥3 months;
- 6\. Adequate bone marrow reserve and organ function as defined below:
- Bone marrow reserve: Peripheral WBC \< 25 × 10⁹/L (leukocyte-reducing agents are allowed, with a washout period of at least 5 half-lives prior to study drug administration);
- Coagulation: International normalized ratio (INR) ≤ 2;
- Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. In cases of hepatic involvement: ALT or AST ≤ 5 × ULN, and TBIL ≤ 3 × ULN;
- Renal function: Creatinine clearance ≥60 mL/min (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤450 ms for males, ≤470 ms for females.
- 7\. Female participants of childbearing potential and fertile male participants with partners of childbearing potential must use medically approved contraception during treatment and for 6 months after the final dose.
What rules you out
- 1\. Known hypersensitivity to WBC100 capsules or any of their excipients;
- 2\. Diagnosis of acute promyelocytic leukemia (APL);
- 3\. Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML transformed from myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN);
- 4\. people with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days;
- 5\. people who have undergone major surgery, have active ulcers, or have unhealed wounds within 28 days prior to the first dose;
- 6\. Received other investigational drugs or treatments within 28 days prior to the first administration, or are still within the safety follow-up period of another clinical trial;
- 7\. people with a history of severe cardiovascular or cerebrovascular conditions, including but not limited to:
- Significant arrhythmias or conduction disorders (e.g., ventricular arrhythmias, Grade II-III AV block);
- Thromboembolic events requiring anticoagulation or presence of vena cava filter;
- NYHA Class III-IV heart failure;
- Poorly controlled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment).
- 8\. Evidence of severe or uncontrolled systemic diseases, such as refractory effusions, poorly controlled diabetes, or significant disorders of the psychiatric, neurological, cardiovascular, respiratory, endocrine...
- 9\. History or presence of immunodeficiency, autoimmune disease requiring systemic immunosuppressants, or organ transplantation;
- 10\. Congestive heart failure, aortic dissection, stroke (excluding lacunar infarct), unstable angina, myocardial infarction, bypass surgery, or pulmonary embolism within 180 days prior to first dosing;
- 11\. Known risk factors for QT prolongation, including congenital long QT syndrome or drug-induced arrhythmia history;
- 12\. Positive for syphilis antibodies, HIV, active HBV infection (HBsAg+ or HBcAb+ with HBV DNA ≥1000 IU/mL), or active HCV infection (HCV Ab+ with detectable HCV RNA);
- 13\. Active infection requiring systemic treatment, including uncontrolled bacterial, viral, or fungal infections;
- 14\. Gastrointestinal conditions preventing oral drug intake or absorption, such as severe vomiting, chronic diarrhea, intestinal stoma, malabsorption, or inability to swallow;
- 15\. Use of strong CYP450 inhibitors/inducers that cannot be stopped ≥7 days before dosing;
- 16\. Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100...
- 17\. Receipt of any live or attenuated vaccines (e.g., influenza, varicella) within 28 days;
- 18\. History of other malignancies within 2 years, except adequately treated basal cell carcinoma, carcinoma in situ of cervix or breast, or squamous cell carcinoma of the skin;
- 19\. History of psychiatric or neurological disorders that may interfere with protocol compliance;
- 20\. Inability to tolerate venous blood draws;
- 21\. Pregnant or breastfeeding women, or women with positive serum hCG during screening;
- 22\. Any condition deemed by the investigator to make the subject unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.