Surovatamig (AZD0486) as Monotherapy in Participants with Relapsed/Refractory (R/R) B-cell NHL - SOUNDTRACK-B

Study identifier:D7404C00001

ClinicalTrials.gov identifier:NCT06526793

EudraCT identifier:N/A

CTIS identifier:2023-505789-27-00

Recruiting

Official Title

A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of surovatamig (AZD0486) in Participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

Medical condition

B-cell Non-Hodgkin Lymphoma, Large B-Cell Lymphoma (LBCL)

Phase

Phase 2

Healthy volunteers

Study drug

Surovatamig

Sex

All

Estimated Enrollment

240

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 27 Nov 2024

Estimated Primary Completion Date: 10 Mar 2027

Estimated Study Completion Date: 14 Jun 2029

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2025 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

• Aged 18 years old and above
• Histologically confirmed relapsed refractory FL (Module 1)
and LBCL (Module 2) after at least 2 prior lines of therapy
• ECOG performance status 0 to 2
• Locally confirmed CD-19 expression in lymphoma cells after
progression from last CD 19 directed therapy
• FDG-avid disease with at least one bi-dimensionally
measurable nodal lesion (defined as > 1.5 cm in its longest
dimension), or extranodal lesion (defined as > 1.0 cm in its
longest dimension)
• Adequate hematological function: ANC ≥ 1000/mm3, platelets
≥ 75,000/mm3, hemoglobin ≥ 9 g/dL.
Transfusion and/or growth factor are allowed but counts must
be stable for at least 72 hours afterwards prior to screening
• Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤
3xULN or < 5 × ULN in the presence of lymphoma involvement of the liver
• Adequate renal function: creatinine clearance (CrCl) of ≥ 45
mL/min
• Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA
The above is a summary, other inclusion criteria details may
apply.
2.

Exclusion Criteria

• Diagnosis of CLL, Burkitt lymphoma, or Richter’s
transformation
• Active CNS involvement by B-NHL
• Leukemic presentation of B-NHL
• History or presence of clinically relevant CNS pathology such
as epilepsy, seizure, paresis, aphasia, stroke, severe brain
injuries, dementia, neurodegenerative disorder including Parkinson’s disease, cerebellar disease,
organic brain syndrome, or psychosis or other severe mental illness
• Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell
Transplantation (HSCT) within 12 weeks, CAR T-
cell therapy within 6 months, or prior allogeneic
HSCT within 24 weeks of first dose of surovatamig
• Requires chronic immunosuppressive therapy
• Unresolved non hematological AEs ≥ Grade 2 from prior
therapies; history of ≥ Grade 3 CRS or neurotoxicity from
prior CAR-T or TCE therapy
• History of major cardiac abnormalities.
• If female, participant must not be pregnant or breastfeeding.
The above is a summary, other exclusion criteria details may
apply.

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Arms	Assigned Interventions
Experimental: Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma In Module 1, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R FL. Surovatamig will be administered as intravenous infusion.	Drug: Surovatamig Investigational Product administered via intravenous infusion. Other Name: AZD0486
Experimental: Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL In Module 2, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R LBCL. Surovatamig will be administered as intravenous infusion.	Drug: Surovatamig Investigational Product administered via intravenous infusion. Other Name: AZD0486

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]