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Trial Title:
A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma
NCT ID:
NCT06561425
Condition:
Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Lymphomas Non-Hodgkin's B-cell
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Conditions: Keywords:
non-Hodgkin lymphoma (NHL)
Follicular lymphoma (FL)
Marginal zone lymphoma (MZL)
Mantle cell lymphoma (MCL)
Burkitt lymphoma (BL)
Primary central nervous system lymphoma (PCNSL)
Diffuse large B-cell lymphoma (DLBCL)
CAR T-cell therapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
GLPG5101
Description:
Autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy
Arm group label:
Phase 1 (Dose escalation phase): Dose level 1
Arm group label:
Phase 1 (Dose escalation phase): Dose level 2
Arm group label:
Phase 1 (Dose escalation phase): Dose level 3
Arm group label:
Phase 2 (Dose expansion phase): BL
Arm group label:
Phase 2 (Dose expansion phase): DLBCL
Arm group label:
Phase 2 (Dose expansion phase): High-risk DLBCL
Arm group label:
Phase 2 (Dose expansion phase): Indolent B-cell NHL
Arm group label:
Phase 2 (Dose expansion phase): MCL
Arm group label:
Phase 2 (Dose expansion phase): PCNSL
Other name:
19CP02
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 phase is to see which dose of GLPG5101 works best with the least number of
side effects.
- In the second phase, all participants will get the best dose of the first phase.
Detailed description:
Phase 1 Dose escalation phase:
The dose escalation phase is designed to select the optimal dose based on efficacy and
safety outcomes.
Three dose levels of GLPG5101 will be evaluated to determine the recommended phase 2 dose
(RP2D).
Participants with aggressive or indolent forms of Relapsed/Refractory B-cell Non-Hodgkin
Lymphoma (r/r NHL) including follicular lymphoma (FL), marginal zone lymphoma (MZL),
mantle cell lymphoma (MCL), and aggressive Diffuse large B-cell lymphoma (DLBCL) will be
enrolled.
Phase 2 Dose expansion phase:
After completion of the dose escalation phase, the dose expansion phase of the study will
proceed per sponsor decision.
During this phase of the study, participants will be enrolled into separate disease
cohorts as defined by their NHL subtype:
1. DLBCL
2. High-risk DLBCL
3. FL and MZL
4. MCL
5. Burkitt lymphoma (BL)
6. Primary central nervous system lymphoma (PCNSL)
Participants per disease cohort will be treated at the RP2D.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Histologically confirmed diagnosis of one of the following NHL subtypes: Aggressive
DLBCL, FL grade 1, 2 or 3A, MZL, or MCL, BL, PCNSL
- Relapsed or refractory disease
- Measurable disease according to the Lugano classification or IPCG criteria for PCNSL
- 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
Key Exclusion Criteria:
- Richter's transformation
- 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)
- Active central nervous system (CNS) involvement (with neurological changes) by
disease under study (exceptions per protocol)
- Infection with human immunodeficiency virus (HIV), active hepatitis B or active
hepatitis C virus
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tufts Medical Center
Address:
City:
Boston
Zip:
02111
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Beth Israel Deaconess Medical Center Clinical Laboratories
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Antwerp University Hospital
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
CHU De Liège
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Cliniques Universitaires Saint-Luc
Address:
City:
Woluwe-Saint-Lambert
Zip:
1200
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Academisch Medisch Centrum
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leiden University Medical Center
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Start date:
March 9, 2022
Completion date:
May 31, 2029
Lead sponsor:
Agency:
Galapagos NV
Agency class:
Industry
Source:
Galapagos NV
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06561425
