Treatment with AZD0486 for patients with relapsed B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Duarte, California, United States Recruiting
• Research Site
  Tampa, Florida, United States Recruiting
• Research Site
  Chicago, Illinois, United States Recruiting
• Research Site
  Waukee, Iowa, United States Recruiting
• Research Site
  Rochester, Minnesota, United States Recruiting
• Research Site
  New York, New York, United States 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GI001 CAR-T for relapsed or refractory B-cell NHL and B-ALL

  This treatment study tests GI001, an in vivo CAR-T therapy, to see if it is safe and helpful for adults with relapsed or refractory B-cell NHL or B-ALL.

  Recruiting Early Phase 1 Hematology department of the 920th hospital · Yunnan, Kunming · NCT07862010

• CT1190B cell therapy for relapsed/refractory large B-cell lymphoma

  This study tests CT1190B cells in adults with relapsed or refractory LBCL to see if they are safe and can help shrink tumors.

  Recruiting Phase 1/2 UCARsgen Biotech Limited · Shanghai, Shanghai Municipality and 2 other locations · NCT07823829

• ARC-02 with Rituximab for B-cell non-Hodgkin lymphomas

  This study tests ARC-02, together with Rituximab, to see if the treatment is safe and shows early signs of activity in people with B-cell non-Hodgkin lymphomas who have already tried multiple therapies.

  Recruiting at 3 sites Phase 1 Taiho Oncology, Inc. · Los Angeles, California and 27 other locations · NCT07691606

• SHR-3079 in B-cell non-Hodgkin lymphoma

  This small early study tests SHR-3079 in adults with B-cell non-Hodgkin lymphoma to see if it is safe and tolerable and to find a workable dose for future testing.

  Recruiting at 2 sites Phase 1 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07661537

• Rocbrutinib and Lacutoclax in B-cell cancers

  This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

  Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

• SCTB35 plus Lenalidomide for relapsed or refractory follicular lymphoma

  This trial tests whether SCTB35 given with Lenalidomide can help people whose follicular lymphoma has come back or stopped responding to prior treatment.

  Recruiting Phase 3 Sinocelltech Ltd. · Beijing, Beijing Municipality · NCT07562022

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.