Actively Recruiting
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
Led by NovaOnco Therapeutics Co., Ltd. · Updated on 2025-03-04
168
Participants Needed
4
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies
CONDITIONS
Official Title
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent
- Age 18 to 75 years, any gender
- For dose escalation: mature B-cell malignant tumors confirmed by 2017 WHO classification; relapsed/refractory with no suitable treatment options
- For dose expansion: histologically confirmed B-cell lymphoma (DLBCL or other B-cell lymphoma) or myeloid tumors (AML, MDS) per WHO classification
- Indolent B-NHL patients must have received at least two systemic therapies including anti-CD20 antibodies; CLL/SLL must have had two systemic therapies including BTK or BCL-2 inhibitors; MCL must have had two systemic therapies
- Aggressive B-NHL (DLBCL) patients must have failed or relapsed after two systemic therapies and be unsuitable for stem cell transplant
- AML patients meet relapsed/refractory criteria as per Chinese guidelines
- MDS patients have intermediate to high risk (IPSS-R >3), relapsed or refractory
- At least one measurable lesion for B-cell lymphoma
- Willing to undergo bone marrow aspiration/biopsy
- ECOG score 0-1 for dose escalation; 0-2 for dose expansion
- Expected survival of at least 3 months
- Adequate bone marrow function with specified blood count thresholds
- Adequate liver, kidney, and coagulation function within 7 days before first dose
- Negative pregnancy test for women of childbearing potential; agree to reliable contraception
- Able to comply with study procedures and visits
You will not qualify if you...
- Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma
- Acute promyelocytic leukemia, BCR-ABL positive AML, or history of myeloproliferative neoplasms
- Use of cytotoxic, investigational, or antitumor drugs within 14 days or 5 half-lives before first dose (except hydroxycarbamide and leukapheresis); tumor immunotherapy within 4 weeks
- Major surgery within 4 weeks before first dose or expected during study
- Systemic radiotherapy within 4 weeks before first dose
- Unresolved toxic reactions > grade 1 from prior treatments (with some exceptions)
- Previous allogeneic stem cell transplant; autologous transplant or immune cell therapy within 3 months (B-cell) or 6 months (AML/MDS)
- CNS involvement with lymphoma/leukemia
- Severe gastrointestinal diseases affecting drug absorption
- Ocular lesions unless treated and cured
- Active or unstable cardiovascular/cerebrovascular diseases including severe arrhythmias, recent acute coronary events, NYHA class ≥ II, LVEF <50%, prolonged QTc, uncontrolled hypertension
- History of interstitial lung disease or active pneumonia
- Congenital immune deficiency or active autoimmune diseases
- Coagulopathy or current use of anticoagulants
- Severe allergies or allergies to study drug components
- Uncontrolled infections; positive for hepatitis B, C, or HIV with active infection
- Other active primary cancers except cured basal or squamous cell skin cancers or carcinoma in situ
- Use of systemic immunosuppressants or corticosteroids ≥10 mg prednisone within 2 weeks before first dose
- Use of strong CYP3A inhibitors or inducers within 2 weeks before first dose
- Pregnant or breastfeeding women
- Any other severe or uncontrolled diseases or lab abnormalities making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangdong, China
Not Yet Recruiting
3
Affiliated Hospital of Hebei University
Hebei, China
Actively Recruiting
4
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
Not Yet Recruiting
Research Team
J
Jun Zhu, MD
CONTACT
Y
Yuqin Song, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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