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B-cell LymphomaPhase 1NCT06820268

A Study of XS-04 in Patients With Relapsed or Refractory Hematologic Malignancies

A Phase 1 study testing XS-04 tablet in people with B-cell Lymphoma and Acute Myeloid Leukemia, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
XS-04 tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
4 sitesChina
Study dates
14 Jan 2025to 15 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must meet all of the following conditions to be enrolled:
  • Voluntarily participate in the clinical trial and sign the informed consent form (ICF).
  • Age ≥18 years, ≤75 years, regardless of gender.
  • Dose escalation phase: Patients with mature B-cell malignant tumors confirmed by histopathology according to the 2017 World Health Organization (WHO) classification, who have failed existing treatments and have no suitable treatment options and have treatment indications.
  • Dose expansion phase: Patients with B-cell lymphoma confirmed by histopathology according to the 2017 WHO classification (cohort 1 includes DLBCL patients, cohort 2 includes other B-cell lymphoma patients), and patients with myeloid tumors confirmed according to the 2016 WHO classification (cohort 3 includes AML, MDS patients).
  • Meet the following disease-specific criteria (tumor types not listed below will be discussed by the sponsor and the investigators to decide if they can be enrolled):
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  • For indolent B-NHL (follicular lymphoma [FL], marginal zone lymphoma [MZL], and Waldenström macroglobulinemia [WM]), patients must have received at least two lines of systemic therapy, including at least one line of combination therapy containing anti-CD20 antibodies; for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), patients must have received at least two lines of systemic therapy, including BTK inhibitors or BCL-2 inhibitors; for MCL, patients must have received at least two lines of systemic therapy (including anti-CD20 antibodies, BTK inhibitors, etc.); for aggressive B-NHL (DLBCL), patients must have failed or relapsed after at least two lines of systemic therapy and are not suitable for hematopoietic stem cell transplantation.
  • For AML, diagnosed according to the 2016 World Health Organization (WHO) classification, meeting the definition of relapsed/refractory as per the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition)";
  • For MDS, pathologically confirmed MDS meeting the WHO 2016 classification criteria; and prognostic scoring system assessment as intermediate to high risk (IPSS-R score >3), relapsed or refractory;
  • B-cell lymphoma patients must have at least one radiographically measurable lesion (i.e., lymph node with long diameter [LDi] >1.5 cm, extranodal lesion with LDi >1.0 cm).
  • Patients must be willing to undergo bone marrow aspiration and/or bone marrow biopsy.
  • ECOG score of 0-1 for dose escalation phase; 0-2 for dose expansion phase.
  • Expected survival time ≥3 months.
  • For mature B-cell malignant tumors, during the screening period, there must be sufficient bone marrow not dependent on growth factor support, according to local laboratory reference ranges, as follows:
  • Absolute neutrophil count (ANC) ≥1.0×10^9/L (patients with neutrophils <1.0×10^9/L due to lymphoma bone marrow infiltration may be enrolled at the investigator's discretion); b. Platelets ≥75×10^9/L (dose escalation phase), platelets ≥50×10^9/L (dose expansion phase), no transfusion within 14 days before the first dose; c. Hemoglobin ≥80 g/L. For AML, white blood cell count (WBC) must be ≤20×10^9/L (hydroxycarbamide treatment to reduce white blood cells is allowed).
  • Adequate organ function, with laboratory tests within the following requirements within 7 days before the first dose:
  • Liver function: Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, total bilirubin ≤1.5×upper limit of normal (ULN); if there is liver involvement, AST, ALT ≤5×ULN; total bilirubin ≤3×ULN;
  • Kidney function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula;
  • Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (aPTT) ≤1.5×ULN.
  • Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose during the screening period. Patients must agree to use reliable contraception methods from signing the informed consent form to 3 months after the last dose. These include but are not limited to: abstinence, male vasectomy, female sterilization surgery, effective intrauterine contraceptive device, effective contraceptive drugs.
  • Patients must be able to comply with study procedures and protocol-specified visits.

Who cannot join

  • Patients meeting any of the following conditions are not eligible for this clinical study:
  • Burkitt lymphoma/leukemia, plasma cell myeloma, plasmablastic lymphoma.
  • Acute promyelocytic leukemia (APL) or BCR-ABL positive AML patients or those with a history of myeloproliferative neoplasms (MPN).
  • Use of other cytotoxic drugs, investigational drugs, or other antitumor drugs within 14 days or 5 half-lives before the first dose of the study drug (whichever is shorter) (except hydroxycarbamide and leukapheresis). Patients who received tumor immunotherapy, antibody, or peptide antitumor drug treatment within 4 weeks before the first dose of the study drug.
  • Patients who underwent therapeutic surgery other than diagnostic, biopsy, or drainage procedures within 4 weeks before the first dose of the study drug, or who are expected to undergo major surgery during the study. For patients who underwent drainage procedures (e.g., thoracic, biliary, etc.) and/or placement of drainage tubes within 4 weeks before the study drug, related symptoms/signs must have substantially resolved, and no prophylactic/therapeutic use of antibiotics is required.
  • Systemic radiotherapy within 4 weeks before the first dose of the study drug.
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  • Unresolved toxic reactions from previous antitumor treatments (> NCI-CTCAE 5.0 grade 1), alopecia, pigmentation, neurotoxicity, or other toxicities assessed by the investigator as chronic and not affecting the safety of the study drug, resolved to NCI-CTCAE 5.0 grade 2 or below are allowed for enrollment.
  • Previous allogeneic stem cell transplantation; autologous stem cell transplantation or adoptive immune cell therapy within 3 months before the first dose of the study drug (mature B-cell malignant tumor patients) or within 6 months (AML, MDS patients).
  • Patients with lymphoma/leukemia involving the central nervous system (CNS).
  • Dysphagia, or a history of severe gastrointestinal disease (e.g., active inflammatory bowel disease, gastrointestinal perforation) with symptoms that cannot be reasonably controlled; or gastrointestinal diseases affecting drug absorption (e.g., Crohn's disease, ulcerative colitis, ileus, short bowel syndrome) or other malabsorption conditions.
  • Patients with ocular conjunctival, corneal lesions (can be enrolled after treatment of ocular lesions is cured).
  • Patients with active or unstable cardiovascular and cerebrovascular diseases, including but not limited to:
  • Severe cardiac rhythm or conduction abnormalities requiring clinical intervention;
  • Acute coronary syndrome, congestive heart failure, myocardial infarction, unstable angina, coronary/peripheral artery bypass grafting, cerebral infarction, cerebral hemorrhage, pulmonary embolism, deep vein thrombosis (within 3 months before the first dose) or other severe cardiovascular events within 6 months before the first dose;
  • New York Heart Association (NYHA) heart function classification ≥II;
  • Left ventricular ejection fraction (LVEF) <50%;
  • Presence of torsades de pointes, congenital long QT syndrome;
  • QTcF >450ms (male) or >470ms (female);
  • Uncontrolled hypertension despite optimal treatment (defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg under medication control).
  • History of interstitial lung disease (ILD), pulmonary interstitial fibrosis; or evidence of active pneumonia on chest CT scan during the screening period.
  • Patients with congenital immune deficiency diseases, or active autoimmune diseases, including but not limited to active and uncontrolled autoimmune cytopenia, persisting for 2 weeks or longer, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
  • Patients with coagulopathy (e.g., hemophilia).
  • Currently using anticoagulant drugs.
  • History of severe allergies, or allergies to any active or inactive components of the study drug.
  • Uncontrolled systemic infection (viral, bacterial, fungal) within two weeks before the first dose of the study drug; hepatitis B surface antigen positive and hepatitis B virus DNA exceeding 1000 IU/ml; hepatitis C virus (HCV) antibody positive or HCV RNA positive; human immunodeficiency virus (HIV) antibody positive.
  • Patients with other primary malignant neoplasms, the following conditions can be enrolled: cured and completely excised basal cell and squamous cell skin cancer, completely excised carcinoma in situ of any type.
  • Need to continue using systemic immunosuppressants or systemic corticosteroids (≥10mg prednisone or equivalent of other corticosteroids) within two weeks before the study drug.
  • Use of strong CYP3A inhibitors or inducers within two weeks before the first dose.
  • Pregnant or lactating women.
  • Any other severe or uncontrolled acute or chronic disease or laboratory test abnormality or other reasons deemed unsuitable for participation in this clinical study by the investigator.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jun Zhu, MD contact

88196922

zhujun3346@163.com

Yuqin Song, MD contact

88196922

SongYQ_VIP@163.com

China4 sites, 4 recruiting

  • Beijing Cancer Hospital

    Beijing

    Yuqin Song, MD, 88196922, SongYQ_VIP@163.com

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangdong

    Qingqing Cai, MD, 13798101121, caiqq@sysucc.org.cn

    Not yet recruiting

  • Affiliated Hospital of Hebei University

    Hebei

    Youchao Jia, MD, 18330211981, youchaojialcsy@163.com

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Hubei

    Fang Zhu, MD, 13871545106 ext. caiqq@sysucc.o, zhufang1226@126.com

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I Trial to Evaluate the Tolerability, Pharmacokinetics and Preliminary Efficacy of XS-04 in Patients With Hematologic Malignancies

Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies

Read the detailed description

Main Objective: To evaluate the safety and tolerability of XS-04 tablets in patients with relapsed or refractory hematologic malignancies. To determine the maximal tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of XS-04 tablets. Secondary Objective: To determine the pharmacokinetic (PK) characteristics of XS-04 tablets after single and multiple oral administrations. To preliminarily evaluate the efficacy of XS-04 tablets in patients with relapsed or refractory hematologic malignancies. Exploratory Objective: To preliminarily assess the metabolic transformation characteristics after oral administration of XS-04 tablets. To evaluate the population PK and exposure-effect (E-R) relationship. To explore the association between relevant biomarkers and drug efficacy; to explore the correlation between PD biomarkers and PK. To assess the impact of food on the PK characteristics of orally administered XS-04 tablets in patients.

Being tested
XS-04 tablet
Medical subject headings
Lymphoma, B-Cell, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XS-04 tabletDrug

    Each treatment cycle is 28 days, with continuous oral administration, twice daily.

Study groups in NCT06820268
Study groupRoleWhat they receive
A multicenter, open-label, single-arm Phase I dose-escalation and dose-expansion clinical studyExperimentalFor drugs, use the generic name and include dosage form, dosage, frequency, and duration. Note: Group description not yet entered.] XS-04 tablet specifications: 0.5 mg, 5 mg, 20 mg. Dose escalation phase: 1 mg, 3 mg, 10 mg, 20 mg, 40 mg, 80 mg, 120 mg, 160 mg/day (dose adjustment allowed based on actual escalation situation); Cycle 0 phase, oral administration once (dose is half of the total daily dose for the respective dose group), observe for two days (based on the PK results of the first 1-2 dose groups, decide whether the remaining dose groups need Cycle 0 phase); thereafter Cycle 1-N phase, each 28 days is one treatment cycle, continuous administration, two times daily. Dose regimen adjustments are allowed based on PK, safety, and efficacy data in this trial. Dose expansion phase: Based on the results of the dose escalation phase, cohort one and cohort two are planned to use the RP2D dose, cohort three safety lead-in phase is
Receives: Drug: XS-04 tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs)

    Safety indicators

    Measured: At the end of C1D21(each cycle is 28 days)

  2. Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D)

    Safety indicators and efficacy indicators

    Measured: Up to 24 months

Secondary outcomes (5)

  1. The occurrence of adverse events (AEs) reported in all subjects who received study drug

    Safety indicators

    Measured: From enrollment up to 30 days after last dose

  2. The occurrence of treatment-emergent adverse events (TEAs)

    Safety indicators

    Measured: From first dose up to 30 days after last dose

  3. Pharmacokinetic variables including maximum plasma concentration (Cmax)

    Safety indicators

    Measured: Cycle1(28days）

  4. Pharmacokinetic variables including maximum plasma concentration (Cmin)

    Safety indicators

    Measured: Cycle1(28days）

  5. PK Parameters After Single and Multiple Oral Doses of XS-04 Tablets

    Safety indicators

    Measured: Cycle 0 to Cycle 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2025
  2. Study start14 Jan 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion15 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
A multicenter, open-label, single-arm Phase I dose-escalation and dose-expansion clinical study
Masking
None (open label)
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06820268
Sponsor's protocol ID
XS-04-I101
Status last verified
Sep 2026
First submitted
9 Jan 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XS-04 tablet in people with B-cell Lymphoma and Acute Myeloid Leukemia, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Zhu, MD (88196922, zhujun3346@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence of treatment-related adverse events meeting the criteria for dose limiting toxicities (DLTs) (time frame: At the end of C1D21(each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06820268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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