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Recruiting Phase 3

Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)

NCT07509151 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2026-05-05
Last updated
2026-10-06

Condition(s) studied

Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV

Investigational drug(s) / intervention(s)

Surovatamig →

Surovatamig: Surovatamig will be administered as a subcutaneous injection.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) — Up to 5 years
    To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.
  • Phase III- Progression Free Survival (PFS) — Until disease progression or death (up to 5 years)
    PFS is defined as the time from date of randomisation until disease progression or death due to any cause, whichever occur first based on International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria, as assessed by independent review committee (IRC).
  • DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs — Up to 5 years
    To assess the safety and tolerability of SC surovatamig as consolidation therapy using dose optimisation in CLL/SLL participants with uIGHV. Also, to determine the RP3D of SC surovatamig monotherapy as consolidation therapy in CLL/SLL participants with uIGHV.

Trial sites (44)

FacilityCityRegionStatus
Research Site La Jolla California Not Yet Recruiting
Research Site Denver Colorado Not Yet Recruiting
Research Site New Haven Connecticut Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Kansas City Kansas Not Yet Recruiting
Research Site Louisville Kentucky Not Yet Recruiting
Research Site Bethesda Maryland Not Yet Recruiting
Research Site Boston Massachusetts Not Yet Recruiting
Research Site Rochester Minnesota Not Yet Recruiting
Research Site Basking Ridge New Jersey Not Yet Recruiting
Research Site Rochester New York Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Pittsburgh Pennsylvania Not Yet Recruiting
Research Site Houston Texas Not Yet Recruiting
Research Site Adelaide Australia Recruiting
Research Site Fitzroy Australia Not Yet Recruiting
Research Site Heidelberg Australia Recruiting
Research Site Nedlands Australia Recruiting
Research Site Perth Australia Recruiting
Research Site Rockingham Australia Not Yet Recruiting
Research Site Calgary Alberta Recruiting
Research Site Vancouver British Columbia Suspended
Research Site Halifax Nova Scotia Recruiting
Research Site Hamilton Ontario Not Yet Recruiting
Research Site Toronto Ontario Recruiting
Research Site Montreal Quebec Suspended
Research Site Montreal Quebec Recruiting
Research Site Québec Quebec Suspended
Research Site Adapazarı Turkey (Türkiye) Recruiting
Research Site Antalya Turkey (Türkiye) Recruiting
Research Site Istanbul Turkey (Türkiye) Not Yet Recruiting
Research Site Istanbul Turkey (Türkiye) Recruiting
Research Site Istanbul Turkey (Türkiye) Recruiting
Research Site Kocaeli Turkey (Türkiye) Recruiting
Research Site Mezitli Turkey (Türkiye) Recruiting
Research Site Edinburgh United Kingdom Recruiting
Research Site Hampshire United Kingdom Recruiting
Research Site Leeds United Kingdom Not Yet Recruiting
Research Site London United Kingdom Recruiting
Research Site London United Kingdom Recruiting

+ 4 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07509151 on ClinicalTrials.gov ↗ ← All trials in the UK