Recruiting
Phase 3

Surovatamig

Sponsor:

AstraZeneca

Code:

NCT07509151

Conditions

Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV

Eligibility Criteria

Sex: All

Age: 18

Healthy Volunteers: Not accepted

Interventions

Surovatamig

Study Details

Brief 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).

Conditions

Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV

Study ID

NCT07509151

Start date

May 5, 2026

Status verified date

Sep, 2026

Completion date

Apr 5, 2032

Anticipated

Primary completion date

Aug 29, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Optimisation and Safety run-in (DOSRI)- Surovatamig Dose 1

Participants will receive Surovatamig Dose 1 subcutaneously (SC) for 6 cycles (each cycle is 28 days in length).

experimental: DOSRI-Surovatamig Dose 2

Participants will receive Surovatamig Dose 2 SC for 6 cycles (each cycle is 28 days in length).

experimental: Phase III-Arm A: Surovatamig SC

Participants will receive Surovatamig at RP3D subcutaneously for 6 cycles (each cycle is 28 days in length).

no intervention: Phase III-Arm B: Observation

Participants will undergo observation for 24 weeks.

Interventions

Surovatamig

Surovatamig will be administered as a subcutaneous injection.

Primary outcome measure

  • DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]
  • Phase III- Progression Free Survival (PFS) [ Time Frame: Until disease progression or death (up to 5 years) ]
  • DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2L7

More Information

Sponsor

AstraZeneca

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Leukaemia
  • Lymphoma
  • Monoclonal IgG4 antibody
  • Consolidation therapy
  • Therapeutic benefit
  • Induction therapy
  • B-cell malignancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.