Recruiting
Phase 2

AZD0486

Sponsor:

AstraZeneca

Code:

NCT06526793

Conditions

B-cell Non-Hodgkin Lymphoma

Follicular Lymphoma (FL)

Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surovatamig

Study Details

Brief summary:

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (AZD0486) monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for LBCL.

Conditions

B-cell Non-Hodgkin Lymphoma

Follicular Lymphoma (FL)

Large B-Cell Lymphoma (LBCL)

Study ID

NCT06526793

Start date

Nov 27, 2024

Status verified date

Aug, 2026

Completion date

Oct 21, 2032

Anticipated

Primary completion date

Apr 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

1. Key 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. Key Exclusion Criteria:

  • Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
  • Active CNS involvement by B-NHL
  • Leukemic presentation of B-NHL
  • History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, 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.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Surovatamig

Investigational Product administered via intravenous infusion.

Primary outcome measure

  • Overall response rate (ORR) (central review) [ Time Frame: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months. ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Duarte, California, United States, 91010

Research Site

Recruiting

Tampa, Florida, United States, 33612

Research Site

Recruiting

Chicago, Illinois, United States, 60637

Research Site

Recruiting

Waukee, Iowa, United States, 50263

Research Site

Recruiting

Rochester, Minnesota, United States, 55905

Research Site

Recruiting

New York, New York, United States, 10016

Research Site

Recruiting

Charlotte, North Carolina, United States, 28204

Research Site

Recruiting

Columbus, Ohio, United States, 43210

Research Site

Recruiting

Portland, Oregon, United States, 97239

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Research Site

Recruiting

Nashville, Tennessee, United States, 37203

Research Site

Recruiting

Austin, Texas, United States, 78704

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Milwaukee, Wisconsin, United States, 53226

Research Site

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Research Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

AstraZeneca

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • AZD0486
  • Surovatamig
  • Follicular Lymphoma (FL)
  • Large B-Cell Lymphoma (LBCL)
  • Non-Hodgkin lymphoma (NHL)
  • Relapsed/Refractory

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-13.