OncoMatch/Clinical Trials/NCT06820268
A Study of XS-04 in Patients with Relapsed or Refractory Hematologic Malignancies
Is NCT06820268 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06820268 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplantation, autologous stem cell transplantation, adoptive immune cell therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify