Study on Zanubrutinib and Tafasitamab for Mantle Cell Lymphoma

Inclusion Criteria

• Adults aged 18 and older.
• Must have a confirmed diagnosis of mantle cell lymphoma (MCL).
• Must have a PET/CT scan showing active cancer lesions that can be measured.
• Must need treatment as determined by the study doctor.
• Must be in good general health with an ECOG performance status of 0 to 2.
• Must have a life expectancy of more than 4 months.
• Must agree to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose.
• Must have normal organ and bone marrow function, including:
  • Neutrophil count over 1,000/mm3 (or over 700/mm3 if cancer affects bone marrow or spleen).
  • Platelet count over 70,000/mm3 (or over 50,000/mm3 if cancer affects bone marrow or spleen).
  • Hemoglobin over 9 g/dL (or over 8 g/dL if cancer affects bone marrow).
  • Total bilirubin within normal limits (or up to 3 times normal if due to liver involvement).
  • Liver enzymes (GGT, AST, ALT) within 2.5 times normal limits.
  • Normal creatinine levels or creatinine clearance of at least 40 mL/min (or 30 mL/min if due to cancer).

Phase 1 Only:

• Patients with relapsed MCL who have had 1 to 3 previous treatments, regardless of previous BTK inhibitor use.

Phase 2 Only:

• Patients with untreated symptomatic MCL not eligible for intensive combination immunochemotherapy.

Exclusion Criteria

• Currently receiving other experimental treatments.
• Known cancer spread to the brain or spinal cord.
• Uncontrolled health issues like heart disease, recent heart attack or stroke, liver cirrhosis, or autoimmune disorders needing long-term steroids.
• Significant heart rhythm issues or abnormal ECG.
• Other cancers unless treated and disease-free for 5 years.
• Active cancer needing treatment.
• HIV positive and needing antiviral therapy.
• Pregnant or breastfeeding women.
• Active hepatitis B or C infection unless controlled.
• Taking certain medications that affect liver enzymes unless they can be safely stopped.
• Previous stem cell transplant.
• Active infections, including COVID-19.
• Recent live vaccine.
• Serious health conditions that could affect safety or study results.
• Unable to swallow capsules or have digestive issues affecting absorption.
• Recent use of high-dose steroids or certain cancer treatments.
• History of severe bleeding disorders.
• Recent stroke or brain bleeding.
• Recent major surgery.
• Need for blood thinners like warfarin.
• Any contraindications according to Tafasitamab guidelines.
• Impaired decision-making ability.