A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma (Atalanta-1)

Galapagos

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lymphomas Non-Hodgkin's B-cell; Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Treatments: Genetic: GLPG5101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06561425

CP0201-NHL

2022-502661-23-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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195 participants in 9 patient groups

Phase 1 (Dose escalation phase): Dose level 1

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

Phase 1 (Dose escalation phase): Dose level 2

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

Phase 1 (Dose escalation phase): Dose level 3

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

Phase 2 (Dose expansion phase): DLBCL

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

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

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

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

Experimental group

Description:

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.

Treatment:

Genetic: GLPG5101

Phase 2 (Dose expansion phase): MCL

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

Phase 2 (Dose expansion phase): BL

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101

Phase 2 (Dose expansion phase): PCNSL

Experimental group

Description:

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

Treatment:

Genetic: GLPG5101