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A study evaluating the safety and efficacy of GLPG5101 (19CP02) in subjects with non-Hodgkin lymphoma
EU CTIS ID: 2022-502661-23-00
What this study is testing
Phase I dose-escalation phase: Evaluate the safety of GLPG5101 and determine recommended Phase 2 doses (RP2Ds) Phase II dose expansion phase: Evaluate the efficacy of GLPG5101 in the different NHL subtypes
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. 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)
- 6. ECOG performance status of 0-2 (Subjects with ECOG 2 must have serum albumin ≥ 3.4 g/dL)
You likely can't join if
- 2.3 Selected prior treatments as defined in the protocol
- 11.1 Systemic fungal, bacterial, viral, or other infection that is not controlled
- For a complete list of Exclusion criteria, please see section 4.2 of the protocol.
- 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)
- 4.2 Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
- 5.2. Active CNS involvement (lesion on contrast-enhanced CT/MRI brain, malignant B cells in CSF) by disease under study
See the full eligibility criteria
- 1. 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)
- 6. 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.
- 2.3 Selected prior treatments as defined in the protocol
- 11.1 Systemic fungal, bacterial, viral, or other infection that is not controlled
- For a complete list of Exclusion criteria, please see section 4.2 of the protocol.
- 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)
- 4.2 Toxicity from previous anticancer therapy that has not resolved to baseline levels or to ≤ Grade 2
- 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
- 7. 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
- 10. Infection with HIV, hepatitis B or hepatitis C virus
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.