NCT06526793招募中2 期
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)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 270
- 试验地点
- 99
- 主要终点
- Overall response rate (ORR) (central review)
研究概览
简要总结
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.
详细描述
This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of surovatamig (AZD0486) administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL
Experimental
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.
干预措施: Surovatamig (Drug)
Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
Experimental
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.
干预措施: Surovatamig (Drug)
结局指标
主要结局
Overall response rate (ORR) (central review)
时间窗: 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.
Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a Partial Response (PR) or Complete Response (CR) based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review
次要结局
- Duration of response (DoR)(To be assessed up to approximately 5 years.)
- Time to response (TTR)(From the first dose until the first objective response, up to approximately 5 years.)
- Event-free survival (EFS)(To be assessed up to approximately 5 years)
- Progression-free survival (PFS)(To be assessed up to approximately 5 years.)
- Time to next anti-lymphoma (TTNT)(To be assessed up to approximately 5 years.)
- Overall survival (OS)(To be assessed up to approximately 5 years.)
- Minimal residual disease (MRD)(To be assessed up through study completion, up to approximately 5 years)
- Change from baseline in EORTC IL233 scales(To be assessed up through study completion, up to approximately 5 years)
- Change from baseline in FACT-LymS scales(To be assessed up through study completion, up to approximately 5 years)
- Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)(From time of Informed Consent to 90-day safety follow-up visit)
- Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)(From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2)
- Duration of response (DoR)(To be assessed up to approximately 5 years.)
- Complete response (CR) rate (central review)(To be assessed up through study completion, up to approximately 5 years)
- Complete response (CR) rate (investigator assessment)(To be assessed up through study completion, up to approximately 5 years)
- Overall response rate (ORR) (investigator assessment)(Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.)
- Duration of complete response (DoCR)(To be assessed up to approximately 5 years.)
- Time to response (TTR)(From the first dose until the first objective response, up to approximately 5 years.)
- Event-free survival (EFS)(To be assessed up to approximately 5 years)
- Progression-free survival (PFS)(To be assessed up to approximately 5 years.)
- Time to next anti-lymphoma (TTNT)(To be assessed up to approximately 5 years.)
- Overall survival (OS)(To be assessed up to approximately 5 years.)
- Plasma concentrations of surovatamig(From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment)
- Area under the concentration time curve (AUC)(From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment)
- Maximum plasma concentration (Cmax)(From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment)
- Time to maximum plasma concentration (Tmax)(From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment)
- A trough concentration (Cthrough)(From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment)
- Immunogenecity of surovatamig(From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2))
- Change from baseline in EORTC IL233 scales(To be assessed up through study completion, up to approximately 5 years)
- Change from baseline in PGI-T scale(To be assessed up through study completion, up to approximately 5 years)
- Change from baseline in EORTC IL 232 QL2 scores(To be assessed up through study completion, up to approximately 5 years)
- Change from baseline in FACT-LymS scales(To be assessed up through study completion, up to approximately 5 years)
- Minimal residual disease (MRD)(To be assessed up through study completion, up to approximately 5 years)
研究者
研究点 (99)
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