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

Conditions

• Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV

Eligibility Criteria

Sex

ALL

Age

18 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Surovatamig — DRUG
  Surovatamig will be administered as a subcutaneous injection.

Study Details

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).

Key Dates

First listed

Apr 3, 2026

Start date

May 5, 2026

Status verified

Sep 2026

Primary completion

Aug 29, 2031

Completion

Apr 5, 2032

Study Design

Enrollment

420 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (14)