SOUNDTRACK-C1
Research type
Research Study
Full title
A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy versus Observation afterFirst-line Induction Therapy in Participants with ChronicLymphocytic Leukaemia or Small Lymphocytic Lymphoma withUnmutated IGHV (SOUNDTRACK-C1)
IRAS ID
1013258
Contact name
Roser Sanz Casañas
Contact email
Sponsor organisation
ASTRAZENECA FARMACÉUTICA SPAIN, S.A
Clinicaltrials.gov Identifier
Research summary
Leukemia and lymphoma are blood cancers that affect the body's immune system and blood cells. While initial treatments with venetoclax-based therapies can be effective, many patients experience disease recurrence after treatment ends, highlighting a significant unmet need for therapies that can provide more durable disease control, particularly for patients with certain genetic markers.
Traditional chemotherapy treatments have shown limited long-term effectiveness for many patients. Fixed-duration targeted therapies have improved outcomes, but maintaining disease control remains challenging, especially for patients with specific genetic features. There is a need for consolidation therapies (treatments given after initial therapy) that can help prevent cancer from returning.
This study aims to evaluate surovatamig, a specialized antibody that works by connecting immune cells (T-cells) to cancer cells, helping the immune system identify and attack the cancer. The study will assess the safety, tolerability, and effectiveness of surovatamig as a consolidation therapy following venetoclax-based treatment. Researchers will also study how the body processes the drug and its impact on disease control.
The study consists of two parts: Part 1 will determine the optimal safe dose of surovatamig (testing 7.2 mg and 15 mg target doses) with approximately 20 participants. Part 2 will confirm this dose and evaluate effectiveness with about 380 participants, comparing those receiving surovatamig against an observation group. Treatment involves injections under the skin over six 28-day cycles, with follow-up continuing for up to 5 years.
This global clinical trial will include up to 400 participants across multiple countries in North America, South America, Europe, and Asia. The study is sponsored and funded by AstraZeneca AB.REC name
South Central - Oxford B Research Ethics Committee
REC reference
26/SC/0007
Date of REC Opinion
5 Feb 2026
REC opinion
Further Information Favourable Opinion