Clinical Trial Finder

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

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.

Arms

Experimental: Phase 1 (Dose escalation phase): Dose level 1

Participants will receive a single dose of GLPG5101 intravenous (IV) cell suspension for infusion at dose level 1 on Day 0.

Experimental: Phase 1 (Dose escalation phase): Dose level 2

Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 2 on Day 0.

Experimental: Phase 1 (Dose escalation phase): Dose level 3

Participants will receive a single dose of GLPG5101 IV cell suspension for infusion at dose level 3 on Day 0.

Experimental: Phase 2 (Dose expansion phase): DLBCL

Participants with DLBCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Experimental: Phase 2 (Dose expansion phase): High-risk DLBCL

Participants with High-risk DLBCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Experimental: Phase 2 (Dose expansion phase): Indolent B-cell NHL

Participants with indolent B-cell NHL (FL and MZ) will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Experimental: Phase 2 (Dose expansion phase): MCL

Participants with MCL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Experimental: Phase 2 (Dose expansion phase): BL

Participants with BL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Experimental: Phase 2 (Dose expansion phase): PCNSL

Participants with PCNSL will receive a single dose of GLPG5101 IV cell suspension for infusion at RP2D level on Day 0.

Interventions

Genetic: - GLPG5101

Autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy