A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

Launched by GALAPAGOS NV · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying an experimental treatment called GLPG5101 to see if it can help patients with non-Hodgkin lymphoma (NHL). The trial has two phases. In the first phase, researchers will determine the best dose of GLPG5101 that works effectively while causing the fewest side effects. In the second phase, all participants will receive the best dose identified in the first phase. The goal is to evaluate both the safety and effectiveness of this new treatment.

To participate in this trial, individuals should have a confirmed diagnosis of specific types of aggressive non-Hodgkin lymphoma and must be experiencing a return of their disease after previous treatment or have not responded to treatment. Eligible participants should be between the ages of 65 and 74, have good overall health, and meet certain criteria related to their blood and organ function. If you decide to join, you can expect regular check-ups and monitoring throughout the study to assess how well the treatment is working and any potential side effects. This trial is currently recruiting participants, so it may be an option for those looking for new treatment possibilities.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Histologically confirmed diagnosis of 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)
• • Relapsed or refractory disease
• • Presence of at least one measurable lesion according to the Lugano classification (except for PCNSL subjects ineligible for ASCT after induction therapy, Cohort 6b)
• • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Participants with ECOG 2 must have serum albumin ≥ 3.4 gram/deciliter)
• • Adequate bone marrow function
• • Adequate renal, hepatic and pulmonary function
• • Women of childbearing potential must have a negative serum pregnancy test at screening and prior to the first dose of conditioning chemotherapy
• • Women of childbearing potential and all male subjects must agree to use highly effective methods of contraception 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.
• Key Exclusion Criteria:
• • Selected prior treatments as defined in the protocol
• • 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)
• • Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
• • Active central nervous system (CNS) involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study (exceptions per protocol)
• • Clinically significant cardiac disease
• • Primary immunodeficiency
• • Stroke or seizure within 6 months of screening
• • History of autoimmune disease requiring systemic immunosuppression or disease modifying treatment within 28 days before screening
• • Infection with human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C virus
• • Systemic fungal, bacterial, viral, or other infection that is not controlled