A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

Sponsor: Galapagos NV

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06561425

Provider View

This study assesses GLPG5101, an autologous anti-CD19 CAR T cell therapy, in relapsed/refractory B-cell NHL. Phase 1 determines the optimal dose, while Phase 2 evaluates efficacy across specific NHL subtypes. Eligible participants must have confirmed NHL, measurable disease, and adequate organ function. Exclusions include Richter's transformation and certain infections.

Patient Parameters

Program Overview

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.

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.

Eligibility Criteria

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

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