Evaluating GLPG5101 for treating Non-Hodgkin Lymphoma
A Phase I/II, Multicenter Study Evaluating the Feasibility, Safety, and Efficacy of Point-of-care Manufactured GLPG5101 (19CP02) in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This study is testing a new treatment called GLPG5101 to see if it can help people with relapsed or hard-to-treat B-cell Non-Hodgkin Lymphoma feel better and stay safe during treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Galapagos NV Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Boston, Massachusetts and 8 other locations) |
| Trial ID | NCT06561425 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of an experimental treatment called GLPG5101 in patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL). It consists of two phases: the first phase focuses on determining the optimal doses with minimal side effects, while the second phase involves administering the selected doses to different cohorts based on NHL subtypes. Participants will be monitored for efficacy and safety outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed relapsed or refractory B-cell Non-Hodgkin Lymphoma, including various subtypes such as DLBCL, FL, MZL, and MCL.
Not a fit: Patients with non-relapsed or non-refractory forms of Non-Hodgkin Lymphoma or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of Non-Hodgkin Lymphoma.
How similar studies have performed: Other studies have shown promise in treating Non-Hodgkin Lymphoma with novel therapies, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts and 8 other locations
- Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- Antwerp University Hospital — Edegem, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU De Liège — Liège, Belgium (Recruiting)
- Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium (Recruiting)
- Academisch Medisch Centrum — Amsterdam, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Galapagos Medical Information
- Email: medicalinfo@glpg.com
- Phone: +3215342900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.