Clinical trial · Interventional
Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)
A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surovatamig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1
- description
- Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).
- interventionNames
- Drug: Surovatamig
- type
- EXPERIMENTAL
- label
- DOSRI-Surovatamig Dose 2
- description
- Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).
- interventionNames
- Drug: Surovatamig
- type
- EXPERIMENTAL
- label
- Phase III-Arm A: Surovatamig SC
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV. * Treatment received and response at the end of 1L (first-line) finite therapy. * Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion. * ECOG performance status of 0 to 2. * Adequate haematologic, liver, renal and cardiac function. * Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception. * Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms). Exclusion Criteria: * Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL). * Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL. * History of or ongoing confirmed progressive multifocal leukoencephalopathy. * Participants who have any concurrent or history of malignancy. * Participants with: * Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy. * Participants with known history of Heamophagocytic lymphohistiocytosis (HLH). * Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV). * Major cardiac abnormalities. * Prior CLL/SLL-specific therapies. * Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant. * Major surgical procedure. * Known hypersensitivity to surovatamig or any of the excipients of the product.
References
Publications (0)
Data not yet available