New hope for Hard-to-Treat leukemia: Two-Drug combo enters human trials

NCT ID NCT05091424

Recruiting now Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 4 times

Summary

This early-stage trial is testing two drugs, mosunetuzumab and venetoclax, in people with chronic lymphocytic leukemia (CLL) that has come back or stopped responding to treatment. Mosunetuzumab is given as a shot under the skin, and venetoclax is a daily pill. The study will check for safety, side effects, and whether the drugs help shrink the cancer. About 137 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: mosunetuzumab (Lunsumio) and venetoclax (Venclexta)
What this could lead to: If successful, this could offer a new treatment option for people with CLL that has stopped responding to other therapies.
What could go wrong: This is an early Phase 1 trial focused on safety, so it is too soon to know if the drugs will work. Side effects like cytokine release syndrome are possible.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC LYMPHOCYTIC LEUKEMIA CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA

Contacts and locations

Locations

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
RECRUITING

Brescia, Lombardy, 25123, Italy
Asst Grande Ospedale Metropolitano Niguarda
RECRUITING

Milan, Lombardy, 20162, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia
RECRUITING

Sant'Andrea Delle Fratte (PG), Umbria, 06132, Italy
Christie Hospital NHS Trust
RECRUITING

Manchester, M20 4BX, United Kingdom
Chu de Clermont Ferrand
WITHDRAWN

Clermont-Ferrand, 63003, France
Churchill Hospital
RECRUITING

Oxford, OX3 7LE, United Kingdom
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING

Barcelona, 08025, Spain
Huntsman Cancer Institute at The University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States
IUCT Oncopole
WITHDRAWN

Toulouse, 31059, France
Mayo Clinic Rochester
RECRUITING

Rochester, Minnesota, 55902, United States
Memorial Sloan-Kettering Cancer Center
WITHDRAWN

New York, New York, 10065, United States
Monash Medical Centre
RECRUITING

Melbourne, Victoria, 3168, Australia
Osp. San Raffaele
RECRUITING

Milan, Lombardy, 20132, Italy
PRATIA MCM Kraków
RECRUITING

Krakow, 30-727, Poland
Peking University People's Hospital
RECRUITING

Beijing, 100044, China
Peter MacCallum Cancer Center
COMPLETED

East Melbourne, Victoria, 3002, Australia
Princess Alexandra Hospital Woolloongabba
RECRUITING

Woolloongabba, Queensland, 4102, Australia
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Seoul St Mary's Hospital
RECRUITING

Seoul, 06591, South Korea
Southern Medical University Nanfang Hospital
RECRUITING

Guangzhou, 510515, China
The First Affiliated Hospital of Nanchang University
RECRUITING

Nanchang, China
The James Cancer Hospital and Solove Research Institute
RECRUITING

Columbus, Ohio, 43210, United States
Tianjin Institute of Hematology & Blood Diseases Hospital
RECRUITING

Tianjin, 301600, China
Uni of Texas - Md Anderson Cancer Center
WITHDRAWN

Houston, Texas, 77030, United States
Uniklinik Koln
WITHDRAWN

Cologne, 50937, Germany
Universitätsklinikum Augsburg
RECRUITING

Augsburg, 86156, Germany
Universitätsklinikum Ulm
WITHDRAWN

Ulm, 89081, Germany
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
RECRUITING

Wroc?aw, 50-367, Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING

Gda?sk, 80-214, Poland
Yeouido St. Mary's Hospital
RECRUITING

Seoul, 07345, South Korea

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