Last reviewed · How we verify
NCT05219513
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Phase 1 trial testing RO7443904 in Lymphoma, Non-Hodgkin in 53 participants. Terminated before completion.
17 July 2024
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 18 February 2022 |
| Primary completion | 17 July 2024 |
| Estimated completion | 17 July 2024 |
| Sites | 9 locations across Denmark, France, Italy, United Kingdom, Australia, United States |
Drugs / interventions tested
- RO7443904 — full drug profile →
- Glofitamab (glofitamab) — full drug profile →
- Obinutuzumab — 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 first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Glofitamab: First Approval.
Shirley M. · · 2023 · cited 41× · PMID 37285013 · DOI 10.1007/s40265-023-01894-5 -
CD28 co-stimulation: novel insights and applications in cancer immunotherapy.
Lotze MT, Olejniczak SH, Skokos D. · · 2024 · cited 39× · PMID 39054343 · DOI 10.1038/s41577-024-01061-1 -
CD19-CD28: an affinity-optimized CD28 agonist for combination with glofitamab (CD20-TCB) as off-the-shelf immunotherapy.
Sam J, Hofer T, Kuettel C, Claus C, et al · · 2024 · cited 31× · PMID 38437725 · DOI 10.1182/blood.2023023381 -
Bispecific antibody therapies.
de Assis LH, Fassi DE, Hutchings M. · · 2023 · cited 21× · PMID 38066890 · DOI 10.1182/hematology.2023000508 -
Tumor Microenvironment and Immunotherapy-Based Approaches in Mantle Cell Lymphoma.
Saleh K, Cheminant M, Chiron D, Burroni B, et al · · 2022 · cited 18× · PMID 35804999 · DOI 10.3390/cancers14133229 -
Mechanistic insights into resistance mechanisms to T cell engagers.
Cao L, Leclercq-Cohen G, Klein C, Sorrentino A, et al · · 2025 · cited 15× · PMID 40330489 · DOI 10.3389/fimmu.2025.1583044 -
The Evolving Role of Bispecific Antibodies in Diffuse Large B-Cell Lymphoma.
Saleh K, Khoury R, Khalife N, Chahine C, et al · · 2024 · cited 8× · PMID 39063920 · DOI 10.3390/jpm14070666
Verify or expand the search:
- PubMed search for NCT05219513
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Lymphoma, Non-Hodgkin
Currently open trials in the same condition.
- NCT07308132 — A Study of JNJ-95566692 in Participants With Non-Hodgkin Lymphoid Malignancies · Phase 1 · recruiting
- NCT06923397 — Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemother · NA · recruiting
- NCT06660563 — A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell No · Phase 1 · active not recruiting
- NCT06343311 — T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) · Phase 1, PHASE2 · recruiting
- NCT06470438 — A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma · Phase 1 · active not recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
- NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05219513 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
- Last refreshed: 23 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05219513.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing