Treatment with AZD0486 for patients with relapsed B-cell lymphoma
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)
PHASE2 · AstraZeneca · NCT06526793
This study is testing a new treatment called AZD0486 to see if it can help adults with relapsed B-cell lymphoma feel better and stay safe after trying other therapies.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca (industry) |
| Drugs / interventions | CAR T, CAR-T |
| Locations | 94 sites (Phoenix, Arizona and 93 other locations) |
| Trial ID | NCT06526793 on ClinicalTrials.gov |
What this trial studies
This Phase 2 global, multi-center, open-label study evaluates the efficacy, safety, and tolerability of AZD0486 monotherapy in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). The study includes two modules: one for follicular lymphoma (FL) and another for diffuse large B-cell lymphoma (DLBCL). Participants aged 18 to 80 who have received at least two prior lines of therapy will receive AZD0486 via intravenous infusion to assess its effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed relapsed or refractory FL or DLBCL after at least two prior lines of therapy.
Not a fit: Patients who have not received prior CD-19 directed therapy or those with other types of lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell NHL.
How similar studies have performed: Other studies have shown promising results with similar approaches in treating relapsed B-cell NHL, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Phoenix, Arizona and 93 other locations
- Research Site — Phoenix, Arizona, United States (NOT_YET_RECRUITING)
- Research Site — Duarte, California, United States (RECRUITING)
- Research Site — Jacksonville, Florida, United States (NOT_YET_RECRUITING)
- Research Site — Tampa, Florida, United States (RECRUITING)
- Research Site — Chicago, Illinois, United States (NOT_YET_RECRUITING)
- Research Site — Iowa City, Iowa, United States (NOT_YET_RECRUITING)
- Research Site — Waukee, Iowa, United States (RECRUITING)
- Research Site — Overland Park, Kansas, United States (WITHDRAWN)
- Research Site — Rochester, Minnesota, United States (RECRUITING)
- Research Site — St Louis, Missouri, United States (WITHDRAWN)
- Research Site — New Brunswick, New Jersey, United States (WITHDRAWN)
- Research Site — New York, New York, United States (RECRUITING)
- Research Site — Charlotte, North Carolina, United States (RECRUITING)
- Research Site — Columbus, Ohio, United States (RECRUITING)
- Research Site — Portland, Oregon, United States (RECRUITING)
- Research Site — Philadelphia, Pennsylvania, United States (RECRUITING)
- Research Site — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Research Site — Pittsburgh, Pennsylvania, United States (WITHDRAWN)
- Research Site — Nashville, Tennessee, United States (NOT_YET_RECRUITING)
- Research Site — Austin, Texas, United States (NOT_YET_RECRUITING)
- Research Site — Houston, Texas, United States (RECRUITING)
- Research Site — San Antonio, Texas, United States (NOT_YET_RECRUITING)
- Research Site — Milwaukee, Wisconsin, United States (RECRUITING)
- Research Site — Heidelberg, Australia (RECRUITING)
- Research Site — Kogarah, Australia (RECRUITING)
- Research Site — Macquarie University, Australia (RECRUITING)
- Research Site — Nedlands, Australia (RECRUITING)
- Research Site — Porto Alegre, Brazil (SUSPENDED)
- Research Site — São Paulo, Brazil (RECRUITING)
- Research Site — São Paulo, Brazil (RECRUITING)
- Research Site — Barrie, Ontario, Canada (NOT_YET_RECRUITING)
- Research Site — Brampton, Ontario, Canada (RECRUITING)
- Research Site — Ottawa, Ontario, Canada (RECRUITING)
- Research Site — Toronto, Ontario, Canada (RECRUITING)
- Research Site — Chengdu, China (RECRUITING)
- Research Site — Chengdu, China (RECRUITING)
- Research Site — Guangzhou, China (RECRUITING)
- Research Site — Nanchang, China (RECRUITING)
- Research Site — Nanjing, China (RECRUITING)
- Research Site — Nantong, China (RECRUITING)
- Research Site — Shandong, China (RECRUITING)
- Research Site — Shanghai, China (NOT_YET_RECRUITING)
- Research Site — Shanghai, China (RECRUITING)
- Research Site — Tianjin, China (RECRUITING)
- Research Site — Zhengzhou, China (RECRUITING)
- Research Site — Aalborg, Denmark (WITHDRAWN)
- Research Site — Copenhagen, Denmark (RECRUITING)
- Research Site — Vejle, Denmark (RECRUITING)
- Research Site — Montpellier, France (RECRUITING)
- Research Site — Paris, France (RECRUITING)
+44 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma, AZD0486, Surovatamig, Non-Hodgkin lymphoma, Relapsed/Refractory