NCT04077723

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Active, enrolled Phase 1, PHASE2 Last updated 2 March 2026

What this trial tests

Phase 1, PHASE2 trial testing Englumafusp alfa in Lymphoma, Non-Hodgkin in 498 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 August 2019

Primary endpoint
31 March 2027

31 March 2027

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	498
Start date	13 August 2019
Primary completion	31 March 2027
Estimated completion	31 March 2027
Sites	44 locations across Denmark, France, Italy, New Zealand, Belgium, United Kingdom, South Korea, Canada

Drugs / interventions tested

• Englumafusp alfa
• Obinutuzumab — full drug profile →
• Glofitamab (glofitamab) — full drug profile →
• Tocilizumab (tocilizumab) — full drug profile →

Conditions studied

• Lymphoma, Non-Hodgkin — all drugs for Lymphoma, Non-Hodgkin →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Non-Hodgkin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase I/II, open-label, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of englumafusp alfa (RO7227166) in participants with relapsed/refractory Non-Hodgkin's Lymphoma (r/r NHL). Englumafusp alfa will be administered by intravenous (IV) infusion in combination with obinutuzumab and in combination with glofitamab. A fixed dose of obinutuzumab (Gpt; pre-treatment) will be administered up to seven days prior to the first administration of englumafusp alfa and seven days prior to the first administration of glofitamab. This entry-into-human study is divided into a dose-escalation stage (Part I and Part II) and a dose expansion stage (Part III).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bi- and trispecific immune cell engagers for immunotherapy of hematological malignancies.
   Tapia-Galisteo A, Álvarez-Vallina L, Sanz L. · · 2023 · cited 87× · PMID 37501154 · DOI 10.1186/s13045-023-01482-w
2. Overcoming the challenges associated with CD3+ T-cell redirection in cancer.
   Singh A, Dees S, Grewal IS. · · 2021 · cited 82× · PMID 33469153 · DOI 10.1038/s41416-020-01225-5
3. CD137 as an Attractive T Cell Co-Stimulatory Target in the TNFRSF for Immuno-Oncology Drug Development.
   Hashimoto K. · · 2021 · cited 66× · PMID 34064598 · DOI 10.3390/cancers13102288
4. The emerging landscape of novel 4-1BB (CD137) agonistic drugs for cancer immunotherapy.
   Claus C, Ferrara-Koller C, Klein C. · · 2023 · cited 65× · PMID 36727218 · DOI 10.1080/19420862.2023.2167189
5. Ten years in the making: application of CrossMab technology for the development of therapeutic bispecific antibodies and antibody fusion proteins.
   Surowka M, Schaefer W, Klein C. · · 2021 · cited 64× · PMID 34491877 · DOI 10.1080/19420862.2021.1967714
6. Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
   Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
7. Glofitamab: First Approval.
   Shirley M. · · 2023 · cited 41× · PMID 37285013 · DOI 10.1007/s40265-023-01894-5
8. 4-1BB: A promising target for cancer immunotherapy.
   Kim AMJ, Nemeth MR, Lim SO. · · 2022 · cited 38× · PMID 36185242 · DOI 10.3389/fonc.2022.968360