計劃書編號D7407C00001
尚未開始召募
2024-09-01 - 2029-05-25
Phase I
召募中4
一項第I/II期開放性多中心的主要試驗計畫，評估AZD0486單一療法或併用其他抗癌藥物用於罹患成熟B細胞惡性腫瘤參與者的安全性和療效。
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
慢性淋巴球性白血(Chronic lymphocytic leukemia, CLL)
小淋巴球性白血病(Small lymphocytic leukemia , SLL)
外套細胞淋巴瘤(Mantle-cell lymphoma, MCL)
大B 細胞淋巴瘤( Large B-cell lymphoma, LBCL)
試驗目的
評估AZD0486 (以IV 或SC 方式給藥)單一療法以及併用其他抗癌藥物用於成熟B 細胞惡性腫瘤時的安全性和耐受性，並確定其RP2D (in local language)
藥品名稱
N/A
主成份
AZD0486
劑型
N/A
劑量
NA
評估指標
• 依據NCI CTCAE 第5.0 版/ASTCT的AE/SAE 發生率、性質和嚴重度；實驗室檢測資料和生命徵象相較於基期的變化
• DLT 發生率
• AESI 發生率和嚴重度
• 因AE 而停用試驗藥物、降低劑量以及延後劑量的發生率和性質(in local language)
• DLT 發生率
• AESI 發生率和嚴重度
• 因AE 而停用試驗藥物、降低劑量以及延後劑量的發生率和性質(in local language)
主要納入條件
Master Inclusion Criteria 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 Inclusion Criteria:
- 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 lymphocytes <10,000.
- 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 Inclusion Criteria:
- MCL diagnosis per WHO.
- Clinical Stage II, III, or IV by Ann Arbor Classification.
- At least 1 measurable site per Lugano.
- ALC < 10,000.
- Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific Inclusion Criteria:
- Large B-cell lymphoma per WHO 2022.
- R/R B-NHL after at least 1 prior line of therapy.
- International Prognostic Index (IPI) 2-5.
- At least 1 measurable site as per Lugano.
- Left ventricular ejection fraction (LVEF) >50%.
- Contraception at least 90 days after last dose of AZD0486 or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
- 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 Inclusion Criteria:
- 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 lymphocytes <10,000.
- 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 Inclusion Criteria:
- MCL diagnosis per WHO.
- Clinical Stage II, III, or IV by Ann Arbor Classification.
- At least 1 measurable site per Lugano.
- ALC < 10,000.
- Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific Inclusion Criteria:
- Large B-cell lymphoma per WHO 2022.
- R/R B-NHL after at least 1 prior line of therapy.
- International Prognostic Index (IPI) 2-5.
- At least 1 measurable site as per Lugano.
- Left ventricular ejection fraction (LVEF) >50%.
- Contraception at least 90 days after last dose of AZD0486 or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
主要排除條件
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 anticancer 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.
Substudy 1 Specific Exclusion Criteria:
- CLL transformation to more aggressive 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.
- 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 anticancer 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.
Substudy 1 Specific Exclusion Criteria:
- CLL transformation to more aggressive 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.
試驗計畫預計收納受試者人數
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台灣人數
15 人
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全球人數
230 人
