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

NCT06561425 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CP0201-NHL2022-502661-23-00
• Study Type: interventional
• Target: 130
• Locations: 3 countries
• Sites: 10

Brief 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 doses of GLPG5101 work best with the least number of side effects.
• In the second phase, participants will receive the selected dose(s) based on the results in the first phase.

Conditions

Lymphomas Non-Hodgkin&Amp;Amp;#39;s B-Cell; Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

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; Diffuse large B-cell lymphoma - Richter Transformation (DLBCL-RT); small lymphocytic leukemia (SLL); chronic lymphocytic leukemia (CLL)

Outcome Measures

Primary Outcomes (3)

• Phase 1: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

  2 years

• Phase 1: Number of participants with Dose-Limiting Toxicities (DLTs)

  From first dose up to Day 28

• Phase 2: Number of participants with objective response (OR) per the Lugano Classification or International Primary central nervous system lymphoma Collaborative Group (IPCG) criteria for PCNSL or per iwCLL (CLL [Cohort 8] and DLBCL-RT [Cohort 7] only)

  For all cohorts

  2 years

Secondary Outcomes (15)

• Phase 2: Number of participants with AEs and SAEs

  2 years

• Number of participants with AEs of special interests

  2 years

• Number of participants with OR per the Lugano Classification or IPCG criteria

  2 years

• Number of participants with OR per International workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria (DLBCL-RT [cohort 7] only

  2 years

• Number of participants with complete response (CR) per Lugano Classification or IPCG criteria for PCNSL or per iwCLL (CLL [Cohort 8] and DLBCL-RT [Cohort 7] only)

  2 years

Study Arms (13)

Phase 1 (Dose escalation phase): Dose level 1

EXPERIMENTAL

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

Genetic: GLPG5101

Phase 1 (Dose escalation phase): Dose level 2

EXPERIMENTAL

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

Genetic: GLPG5101

Phase 1 (Dose escalation phase): Dose level 3

EXPERIMENTAL

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

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 1a: DLBCL 2L+

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 1b: DLBCL 2L+ SCNSL

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

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

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 3: Indolent B-cell NHL (FL and MZL 3L+)

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 4: MCL 2L+

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 5: BL 2L+

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 6a: PCNSL 2L+

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 6b: PCNSL first-line consolidation

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Phase 2 (Dose expansion phase): Cohort 7: DLBCL-RT 2L+

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Experimental: Phase 2 (Dose expansion phase): Cohort 8 CLL/SLL (r/r)

EXPERIMENTAL

Participants in this cohort will receive a single dose of GLPG5101 IV cell suspension for infusion at the selected RP2D level for this disease subtype on Day 0

Genetic: GLPG5101

Interventions

GLPG5101 GENETIC

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

Also known as: 19CP02

Experimental: Phase 2 (Dose expansion phase): Cohort 8 CLL/SLL (r/r); Phase 1 (Dose escalation phase): Dose level 1; Phase 1 (Dose escalation phase): Dose level 2; Phase 1 (Dose escalation phase): Dose level 3; Phase 2 (Dose expansion phase): Cohort 1a: DLBCL 2L+; Phase 2 (Dose expansion phase): Cohort 1b: DLBCL 2L+ SCNSL; Phase 2 (Dose expansion phase): Cohort 2: High-risk first-line DLBCL; Phase 2 (Dose expansion phase): Cohort 3: Indolent B-cell NHL (FL and MZL 3L+); Phase 2 (Dose expansion phase): Cohort 4: MCL 2L+; Phase 2 (Dose expansion phase): Cohort 5: BL 2L+; Phase 2 (Dose expansion phase): Cohort 6a: PCNSL 2L+; Phase 2 (Dose expansion phase): Cohort 6b: PCNSL first-line consolidation; Phase 2 (Dose expansion phase): Cohort 7: DLBCL-RT 2L+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (10)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU De Liège

Liège, 4000, Belgium

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, 1200, Belgium

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Burkitt Lymphoma; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: March 9, 2022
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); NL (3); BE (4)