Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia

Q: Who can participate in NCT07014449?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07014449?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

An Open-Label, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WBC100 Capsules in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia (NCT07014449) is a Phase 1 interventional studying AML (Acute Myelogenous Leukemia and Relapsed Acute Myelogenous Leukemia, sponsored by Hangzhou Weben Pharma Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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? * Can WBC100 effectively induce remission in R/R AML patients? Participants will: * Take WBC100 capsules orally once daily in 28-day treatment cycles; * Undergo regular safety assessments, including adverse event monitoring and laboratory tests; * Provide blood samples for pharmacokinetic (PK) analysis; * Have their remission status and efficacy evaluated according to the ELN2022 criteria.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For AML (Acute Myelogenous Leukemia, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Signed willing to sign a consent form 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: 1. Bone marrow reserve: Peripheral WBC \< 25 × 10⁹/L (leukocyte-reducing agents are allowed, with a waiting period after previous treatment of at least 5 half-lives prior to study drug administration); 2. Coagulation: International normalized ratio (INR) ≤ 2; 3. 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; 4. Renal function: kidney function (creatinine clearance) at least 60 mL/min (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN; 5. 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. Who Should NOT Join This Trial: - 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\. Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days; - 5\. Subjects who have undergone major surgery, have active ulcers, or have unhealed wounds within 28 days prior to the first dose; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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: 1. 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); 2. Coagulation: International normalized ratio (INR) ≤ 2; 3. 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; 4. Renal function: Creatinine clearance ≥60 mL/min (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN; 5. 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. Exclusion Criteria: * 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\. Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days; * 5\. Subjects 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\. Subjects with a history of severe cardiovascular or cerebrovascular conditions, including but not limited to: 1. Significant arrhythmias or conduction disorders (e.g., ventricular arrhythmias, Grade II-III AV block); 2. Thromboembolic events requiring anticoagulation or presence of vena cava filter; 3. NYHA Class III-IV heart failure; 4. 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, gastrointestinal, hepatic, or renal systems; * 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 days; * 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.

Treatments Being Tested

DRUG

WBC100 QD

WBC100 will be administered orally as capsules once daily in 28-day cycles. The dose-escalation phase follows an accelerated titration combined with the traditional '3+3' design.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07014449), the sponsor (Hangzhou Weben Pharma Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07014449 clinical trial studying?

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? * Can WBC100 effectively induce remission in R/R AML patients? Participants will: * Take WBC100 capsules orally once daily in 28-day treatment cycles; * Undergo regular safety assessments, including adverse event monitoring and laboratory tests; * Provide blood sa… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07014449?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07014449?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07014449. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07014449. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.