An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Latest Information Update: 12 Jan 2026
At a glance
- Drugs Atezolizumab (Primary) ; Mosunetuzumab (Primary) ; Mosunetuzumab (Primary)
- Indications B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma
- Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors Genentech
Most Recent Events
- 22 Dec 2025 According to Roche media release, the USFDA has approved Lunsumio VELO as a subcutaneous (SC) formulation under accelerated approval supported by results from this trial, demonstrating compelling complete response rate in third-line or later follicular lymphoma. Full approval for this regimen may be contingent on confirmation of benefit in a confirmatory trial.
- 22 Dec 2025 According to Genentech Media Release, the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study.
- 08 Dec 2025 According to Genentech Media Release, data from the trial were presented at the 67th American Society of Hematology Annual Meeting and Exposition, December 6-9, 2025 in Orlando, Florida.