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An Open-Label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa (RO7227166, a CD19 Targeted 4-1BB Ligand) in Combination with Obinutuzumab and in Combination with Glofitamab Following a Pre-Treatment Dose of Obinutuzumab Administered in Participants with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502616-37-00
Acronym
BP41072
Enrollment
194
Registered
2024-02-27
Start date
2019-07-30
Completion date
Unknown
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma (r/r B-cell NHL)

Brief summary

Part I/II 1. Nature and frequency of dose-limiting toxicities (DLTs), Part I/II 2. Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 and for CRS the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading, Part III 3. Investigator assessed CR rate as assessed by FDG-PET/CT scan

Detailed description

Part I/II 1. Total exposure (area under the concentration time curve [AUC]) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 2. Maximum serum concentration (peak concentration, Cmax) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 3. Minimum serum concentration (trough concentration, Cmin) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 4. Clearance (CL), Volume of distribution of steady state (Vss) and half-life (t½) if data permit, Part I/II 5. Analysis of dose-linearity in exposure, Part I/II 6. Additional PK parameters may be determined as appropriate, Part I/II 7. Incidence and titer of englumafusp alfa anti-drug antibodies (ADAs) during the study relative to prevalence of ADAs at baseline, Part I/II 8. Overall response rate (ORR), Part I/II 9. Disease control rate (DCR), Part III 10. Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5.0 and for CRS the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading, Part III 11. Total exposure (area under the concentration time curve [AUC]) of englumafusp alfa in combination with glofitamab, Part III 12. Maximum serum concentration (peak concentration, Cmax) of englumafusp alfa in combination with glofitamab, Part III 13. Minimum serum concentration (trough concentration, Cmin) of englumafusp alfa in combination with glofitamab, Part III 14. Clearance (CL), Volume of distribution of steady state (Vss) and half-life (t½) if data permit of englumafusp alfa in combination with glofitamab, Part III 15. Analysis of dose-linearity in exposure, Part III 16. Additional PK parameters may be determined as appropriate, Part III 17. Incidence and titer of englumafusp alfa anti-drug antibodies (ADAs) during the study relative to prevalence of ADAs at baseline, Part III 18. Overall response rate (ORR), Part III 19. Duration of complete response (DOCR), Part III 20. Progression-free survival (PFS), Part III 21. Overall survival (OS), Part III 22.Time to first complete response (TFCR), Part III 23. Time to first overall response (TFOR), Part III 24 Change from baseline in physical function, role function, and HRQoL based on EORTC QLQ C30, Part III 25. Change from baseline in disease-related symptoms based on the FACT-Lym Lymphoma scale, Part III 26. Baseline levels and change from baseline of cellular biomarkers in blood and tumor tissue, using markers of B, and T-cell lineage, Part I/II 27. Baseline levels and change from baseline of cellular biomarkers in blood, using markers of B-, T- and NK-cell lineage

Interventions

DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGCD19 4-1 BBL
DRUGRoActemra 20 mg/mL concentrate for solution for infusion

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part I/II 1. Nature and frequency of dose-limiting toxicities (DLTs), Part I/II 2. Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 and for CRS the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading, Part III 3. Investigator assessed CR rate as assessed by FDG-PET/CT scan

Secondary

MeasureTime frame
Part I/II 1. Total exposure (area under the concentration time curve [AUC]) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 2. Maximum serum concentration (peak concentration, Cmax) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 3. Minimum serum concentration (trough concentration, Cmin) of englumafusp alfa in combination with obinutuzumab and glofitamab, Part I/II 4. Clearance (CL), Volume of distribution of steady state (Vss) and half-life (t½) if data permit, Part I/II 5. Analysis of dose-linearity in exposure, Part I/II 6. Additional PK parameters may be determined as appropriate, Part I/II 7. Incidence and titer of englumafusp alfa anti-drug antibodies (ADAs) during the study relative to prevalence of ADAs at baseline, Part I/II 8. Overall response rate (ORR), Part I/II 9. Disease control rate (DCR), Part III 10. Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5.0 and for CRS the American

Countries

Belgium, Denmark, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026