OncoMatch/Clinical Trials/NCT06820268
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
Is NCT06820268 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies XS-04 tablet for b-cell lymphoma.
Treatment: XS-04 tablet — Evaluation of the safety, tolerability, pharmacokinetics, and preliminary efficacy of XS-04 in patients with relapsed or refractory hematologic malignancies
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy (anti-CD20 antibody)
indolent B-NHL (FL, MZL, WM): at least two lines of systemic therapy, including at least one line of combination therapy containing anti-CD20 antibodies
Must have received: systemic therapy (BTK inhibitor, BCL-2 inhibitor)
CLL/SLL: at least two lines of systemic therapy, including BTK inhibitors or BCL-2 inhibitors
Must have received: systemic therapy (anti-CD20 antibody, BTK inhibitor)
MCL: at least two lines of systemic therapy (including anti-CD20 antibodies, BTK inhibitors, etc.)
Must have received: systemic therapy
aggressive B-NHL (DLBCL): failed or relapsed after at least two lines of systemic therapy and are not suitable for hematopoietic stem cell transplantation
Cannot have received: allogeneic stem cell transplantation
Previous allogeneic stem cell transplantation
Cannot have received: autologous stem cell transplantation
Exception: within 3 months before the first dose (mature B-cell malignant tumor patients) or within 6 months (AML, MDS patients)
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)
Cannot have received: adoptive immune cell therapy
Exception: within 3 months before the first dose (mature B-cell malignant tumor patients) or within 6 months (AML, MDS patients)
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)
Cannot have received: cytotoxic chemotherapy
Exception: except hydroxycarbamide and leukapheresis
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)
Cannot have received: tumor immunotherapy
Patients who received tumor immunotherapy, antibody, or peptide antitumor drug treatment within 4 weeks before the first dose of the study drug
Cannot have received: antibody-drug conjugate
Patients who received tumor immunotherapy, antibody, or peptide antitumor drug treatment within 4 weeks before the first dose of the study drug
Cannot have received: peptide antitumor drug
Patients who received tumor immunotherapy, antibody, or peptide antitumor drug treatment within 4 weeks before the first dose of the study drug
Cannot have received: systemic radiotherapy
Systemic radiotherapy within 4 weeks before the first dose of the study drug
Lab requirements
Blood counts
ANC ≥1.0×10^9/L (exceptions for lymphoma BM infiltration); Platelets ≥75×10^9/L (dose escalation), ≥50×10^9/L (dose expansion), no transfusion within 14 days; Hemoglobin ≥80 g/L; For AML, WBC ≤20×10^9/L (hydroxycarbamide allowed)
Kidney function
Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50 mL/min
Liver function
AST, ALT ≤2.5×ULN, total bilirubin ≤1.5×ULN; if liver involvement, AST, ALT ≤5×ULN; total bilirubin ≤3×ULN
Cardiac function
NYHA class <II; LVEF ≥50%; QTcF ≤450ms (male) or ≤470ms (female); no severe arrhythmia, acute coronary syndrome, CHF, MI, unstable angina, bypass grafting, stroke, PE, DVT within 3-6 months; no torsades de pointes, congenital long QT; no uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
Adequate organ function, with laboratory tests within the following requirements within 7 days before the first dose: Liver function: AST, ALT ≤2.5×ULN, total bilirubin ≤1.5×ULN; if liver involvement, AST, ALT ≤5×ULN; total bilirubin ≤3×ULN; Kidney function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥50 mL/min; Coagulation: INR/PT ≤1.5×ULN; aPTT ≤1.5×ULN. Cardiac: NYHA <II, LVEF ≥50%, QTcF ≤450ms (male) or ≤470ms (female), no severe arrhythmia, acute coronary syndrome, CHF, MI, unstable angina, bypass grafting, stroke, PE, DVT within 3-6 months, no torsades de pointes, congenital long QT, no uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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