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New treatment option for Chronic Lymphocytic Leukaemia
Official title A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
ClinicalTrials.gov ID: NCT06564038
What this study is testing
What is Surovatamig?
Surovatamig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic lymphocytic leukaemia.
Also referred to as AZD0486, TNB-486.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Master applicable to all substudies:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Contraception use during treatment and at least 90 days after final dose.
- Confirmed CD19 expression if prior anti-CD19 therapy. Substudy 1 Specific
- Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
You likely can't join if
- Master Exclusion Criteria applicable to all substudies:
- Central nervous system (CNS) lymphoma.
- Surgery within 14 days of study drug.
- Clinically significant cardiovascular (CV) disease.
- Unresolved Grade \>2 AEs from prior anticancer therapy (except alopecia or fatigue).
- Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
See the full eligibility criteria
- Master applicable to all substudies:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Contraception use during treatment and at least 90 days after final dose.
- Confirmed CD19 expression if prior anti-CD19 therapy. Substudy 1 Specific
- Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
- SLL: at least 1 measurable site per Lugano.
- Absolute lymphocyte count (ALC) \<25000 cells/mcL.
- Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
- Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive. Substudy 2 Specific
- MCL diagnosis per WHO.
- Clinical Stage II, III, or IV by Ann Arbor Classification.
- At least 1 measurable site per Lugano.
- ALC \< 25000 cells/mcL.
- Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi. Substudy 3 Specific
- At least 1 measurable site as per Lugano.
- Left ventricular ejection fraction (LVEF) ≥50%.
- Participant must be no older than 79 years of age at the time of signing ICF.
- Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
- Cohort 3A:
- Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
- R/R B-NHL after at least 1 prior lines of systemic therapy.
- International Prognostic Index (IPI) 2-5.
- Cohort 3B:
- Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
- IPI score of 2 to 5.
- Master Exclusion Criteria applicable to all substudies:
- Central nervous system (CNS) lymphoma.
- Surgery within 14 days of study drug.
- Clinically significant cardiovascular (CV) disease.
- Unresolved Grade \>2 AEs from prior anticancer therapy (except alopecia or fatigue).
- Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
- Radiation therapy within 28 days.
- Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
- Prior Grade \> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
- Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
- Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH). Substudy 1 Specific Exclusion Criteria:
- CLL/SLL transformation to more aggressive form of lymphoma.
- Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist. Substudy 3 Specific Exclusion Criteria:
- Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
- Cumulative dose of anthracycline \>150 mg/m2.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Heidelberg, Australia
- Melbourne, Australia
- Nedlands, Australia
- Beijing, China
- Guangzhou, China
- Jinan, China
- Tianjin, China
- Zhengzhou, China
- Ostrava - Poruba, Czechia
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Hackensack, New Jersey, United States; New Brunswick, New Jersey, United States; New York, New York, United States; Charlotte, North Carolina, United States; Columbus, Ohio, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.