New cell therapy shows promise for tough-to-treat lymphoma
NCT ID NCT06561425
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests an experimental treatment called GLPG5101 for people with B-cell non-Hodgkin lymphoma that has come back or not responded to standard therapy. The treatment is a cell therapy made at the hospital. The study has two phases: first, finding the best dose with the fewest side effects; second, checking how well that dose works. About 130 participants will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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130 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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May 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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), 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Academisch Medisch Centrum (Amsterdam UMC)
Amsterdam, 1105 AZ, Netherlands
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Algemeen Ziekenhuis Delta
Roeselare, 8800, Belgium
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Antwerp University Hospital
Edegem, 2650, Belgium
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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CHU De Liège
Liège, 4000, Belgium
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Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200, Belgium
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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, 3015 GD, Netherlands
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Helsingin Yliopistollinen Sairaala (HUS)
Helsinki, 00029, Finland
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Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
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Tufts Medical Center
Boston, Massachusetts, 02111, United States
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UZ Leuven
Leuven, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New drug joins standard chemotherapy in fight against B-Cell lymphoma
- New antibody tested against aggressive blood cancer
- Which lymphoma drug combo works best? a new study aims to find out
- Can engineered cells beat blood cancers that Won't quit?
- Can engineered immune cells beat tough B-Cell cancers?