A study evaluating the safety and efficacy of GLPG5101 (19CP02) in subjects with non-Hodgkin lymphoma

Korábbi kezelés

• 2.3 Selected prior treatments as defined in the protocol
• 4.2 Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
• Primary immunodeficiency
  • 8.1 Stroke or seizure within 6 months of screening.
  • 9.1 History of autoimmune disease requiring systemic immunosuppression or disease modifying treatment within 28 days before screening

Más betegség

• 11.1 Systemic fungal, bacterial, viral, or other infection that is not controlled
• 3.2 History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 3 years (exceptions per protocol)
• 5.2. Active CNS involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study
• 6.1 Clinically significant cardiac disease
• Infection with HIV, hepatitis B or hepatitis C virus

Egyéb

• For a complete list of Exclusion criteria, please see section 4.2 of the protocol.

• Signed informed consent form
  • 2.1 Age ≥ 18 years at the time of signing informed consent form
  • 3.2 One of the following NHL subtypes: DLBCL, FL grade 1, 2 or 3A, MZL, MCL, BL, PCNSL, DLBCL-RT, High-Grade B-cell Lymphoma (HGBL)
  • 4.3 Relapsed or refractory disease
  • 5.2 Presence of at least one measurable lesion according to the Lugano classification (except for PCNSL subjects ineligible for ASCT after induction therapy, Cohort 6b)
• ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin ≥ 3.4 g/dL)
  • 7.3 & 8.1 Adequate bone marrow, renal, hepatic and pulmonary function
  • 9.1 Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of conditioning chemotherapy
  • 10.1 Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception (failure rate of < 1% per year when used consistently and correctly) and agree to remain on a highly effective method of contraception from the time of signing the informed consent form until at least 12 months after GLPG5101 infusion. Subjects must agree to not donate eggs or sperm during this period.