A phase I/II, multicenter study evaluating the feasibility, safety, and efficacy of point-of-care manufactured GLPG5101 (19CP02) in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma

Conditions

Relapsed/refractory B-cell non-Hodgkin lymphoma

Brief summary

Phase I: Incidence of (S)AEs, Dose-limiting toxicities (DLTs) until Day 28, Phase II: Objective response (OR) until 2 years post GLPG5101 infusion per Lugano Classification or IPCG criteria for PCNSL

Detailed description

1. Type, frequency and severity of (S)AEs (including AEs of special interest) and laboratory abnormalities, 2. OR until 2 years post GLPG5101 infusion per the Lugano classification (for Phase I and Cohort 6b only), 3. OR until 2 years post GLPG5101 infusion per iwCLL criteria (Richter Transformation of DLBCL subtype [DLBCL-RT, Cohort 7] only), 4. Complete response (CR) until 2 years post infusion per Lugano Classification, or IPCG criteria for PCNSL, 5. Duration of response (DOR), 6. Duration of complete response (DOCR), 7. Progression-free survival (PFS), 8. Overall survival (OS), 9. Minimal Residual Disease (MRD) negativity rate at CR (DLBCL, MCL, and DLBCL-RT), 10. Levels of anti-CD19 CAR T cells in blood at peak and over time, 11. Levels of chemokines and cytokines in serum over time, 12. Proportion of successfully manufactured products within the predefined release specifications, 13. Change from baseline in measurement of HRQoL as assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and its CLL-specific module QLQCLL-17 (DLBCL-RT only), and EuroQol EQ-5D-5L

Marie José Kersten, Joost S.P. Vermaat, Pim Mutsaers, Maria T. Kuipers, Évelyne Willems et al. (21 authors)

Blood2025-11-03

10.1182/blood-2025-662

High complete response rates, low dropout rate, and low-grade toxicities in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) receiving GLPG5101, a fresh, early memory-enriched CAR T-cell therapy with a 7-day vein-to-vein time: Results from the ATALANTA-1 DLBCL cohort

Joost S.P. Vermaat, Pim Mutsaers, Sébastien Anguille, Maria T. Kuipers, Évelyne Willems et al. (21 authors)

Blood2025-11-03

10.1182/blood-2025-5940

Atalanta-1: A Phase 1/2 Trial of GLPG5101, a Fresh, Stem-like, Early Memory CD19 CAR T-Cell Therapy with a 7-Day Vein-to-Vein Time, for the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma

Marie José Kersten, Kirsten Saevels, Évelyne Willems, Marte C. Liefaard, Stavros Milatos et al. (15 authors)

Blood2024-11-052 citations

10.1182/blood-2024-205360

Seven-Day Vein-to-Vein Point-of-Care Manufactured CD19 CAR T Cells (GLPG5101) in Relapsed/Refractory NHL: Results from the Phase 1 Atalanta-1 Trial

Marie José Kersten, Kirsten Saevels, Yves Béguin, Joost S.P. Vermaat, Nadia Verbruggen et al. (11 authors)

Blood2023-11-025 citations

10.1182/blood-2023-172736

Interventions

DRUG19CP02

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I: Incidence of (S)AEs, Dose-limiting toxicities (DLTs) until Day 28, Phase II: Objective response (OR) until 2 years post GLPG5101 infusion per Lugano Classification or IPCG criteria for PCNSL	—

Secondary

Measure	Time frame
1. Type, frequency and severity of (S)AEs (including AEs of special interest) and laboratory abnormalities, 2. OR until 2 years post GLPG5101 infusion per the Lugano classification (for Phase I and Cohort 6b only), 3. OR until 2 years post GLPG5101 infusion per iwCLL criteria (Richter Transformation of DLBCL subtype [DLBCL-RT, Cohort 7] only), 4. Complete response (CR) until 2 years post infusion per Lugano Classification, or IPCG criteria for PCNSL, 5. Duration of response (DOR), 6. Duration of complete response (DOCR), 7. Progression-free survival (PFS), 8. Overall survival (OS), 9. Minimal Residual Disease (MRD) negativity rate at CR (DLBCL, MCL, and DLBCL-RT), 10. Levels of anti-CD19 CAR T cells in blood at peak and over time, 11. Levels of chemokines and cytokines in serum over time, 12. Proportion of successfully manufactured products within the predefined release specifications, 13. Change from baseline in measurement of HRQoL as assessed using the European Organization for Rese	—

Measure

Time frame

1. Type, frequency and severity of (S)AEs (including AEs of special interest) and laboratory abnormalities, 2. OR until 2 years post GLPG5101 infusion per the Lugano classification (for Phase I and Cohort 6b only), 3. OR until 2 years post GLPG5101 infusion per iwCLL criteria (Richter Transformation of DLBCL subtype [DLBCL-RT, Cohort 7] only), 4. Complete response (CR) until 2 years post infusion per Lugano Classification, or IPCG criteria for PCNSL, 5. Duration of response (DOR), 6. Duration of complete response (DOCR), 7. Progression-free survival (PFS), 8. Overall survival (OS), 9. Minimal Residual Disease (MRD) negativity rate at CR (DLBCL, MCL, and DLBCL-RT), 10. Levels of anti-CD19 CAR T cells in blood at peak and over time, 11. Levels of chemokines and cytokines in serum over time, 12. Proportion of successfully manufactured products within the predefined release specifications, 13. Change from baseline in measurement of HRQoL as assessed using the European Organization for Rese

—

Countries

Belgium, Finland, Netherlands

Outcome results

None listed