Status:
RECRUITING
A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma
Lead Sponsor:
Galapagos Cell Therapeutics NV
Conditions:
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Lymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is evaluating whether an experimental treatment called GLPG5101 helps to treat non-Hodgkin lymphoma (NHL) and if it is safe to use. This study will be carried out in 2 phases: * The first...
Detailed Description
Phase 1 Dose escalation phase: The dose escalation phase is designed to select the doses for dose expansion based on efficacy and safety outcomes. Three dose levels of GLPG5101 will be evaluated to ...
Eligibility Criteria
Inclusion
- Key
- 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), CLL/SLL
- 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; and except for CLL/SLL subjects without a measurable lesion or a PET positive lesion will be eligible if they have splenomegaly (spleen size \>13 cm) and bone marrow infiltration with lymphoma)
- 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
- 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
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT06561425
Start Date
March 9 2022
End Date
July 1 2029
Last Update
September 23 2025
Active Locations (10)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Antwerp University Hospital
Edegem, Belgium, 2650