EUCTR2018-004124-10-FR进行中（未招募）1 期
A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-1-3 prior lines of therapy, including PI and IMiD
- •-Lenalidomide refractory
- •-Anti-CD38 mAb exposure not required
- •-PD per IMWG criteria =6 months of last regimen; confirmation may be either central or local
- •-Prior SCT allowed (allo: >6 months before apheresis; auto: >12 weeks before apheresis)
- •-Frontline therapy with PI and IMiD
- •-Transplant and non-transplant patients
- •-Anti-CD38 mAb exposure not required
- •-PD per IMWG criteria =12 months of:
- •a. Autologous SCT
- •b. Start of initial therapy (non-transplanted patients)
- •-Previously treated with PI, IMiD, anti-CD38 mAb and BCMA-directed therapy (as monotherapy or in combination)
- •a. Irrespective of dose level or response to prior BCMA-directed therapy
- •-PD per IMWG criteria
- •a. =12 months of last line of therapy
- •b. =6 months of prior therapy, and refractory or non-responsive to their most recent line of therapy
- •Cohort A, B, C:
- •Measurable disease at Screening as defined by any of the following:
- •-Serum M-protein =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
- •-Light chain MM without measurable disease in serum or urine: Serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- •-Central screening lab results required for all study patients:
- •Local laboratory assessments may be used to establish measurable disease at Screening, with local laboratory result =125% of requirements
- •-Lab values as defined in the protocol
- •-Newly diagnosed MM per IMWG with 4 to 8 total cycles of initial therapy, including induction, high-dose therapy and ASCT with or without consolidation
- •a. Previously treated for smoldering myeloma not eligible
- •b. Patient treated with consolidation must have received =2 cycles
- •- Received IMiD or PI or both in combination with steroid as part of induction or consolidation regimen
- •-Tx with alkylating therapy (eg, cyclophosphamide) or mAb during induction/ consolidation permitted
- •-Labs as specified in the protocol
- •For a full list of inclusion criteria, please refer to the protocol, pg 60-78.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Key Exclusion criteria (All cohorts):
- •-Antitumor treatment washout prior to apheresis
- •-Toxicity from previous anticancer therapy must have resolved to baseline or =Grade 1 except alopecia or peripheral neuropathy
- •- Serious underlying medical condition, eg:
- •a.Clinically significant cardiac conditions (CHF, MI, LVEF <45%)
- •b. Active / Hx of autoimmune disease within 3 yrs
- •c. Dementia or altered mental status
- •d. Serious viral, bacterial or uncontrolled systemic fungal infection
- •e. Seropositive for HIV
- •f. Clinically significant Hepatitis B or C infection
- •- Cumulative dose of corticosteroids equivalent to =70 mg of prednisone =7 days prior to apheresis
- •- Stroke or seizure =6 months
- •- Pregnant, breast-feeding or planning to become pregnant / father child while enrolled in study and until 1 year after receiving a JNJ-68284528 infusion
- •a.Cohort D: Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study
- •and until 1 year after receiving a JNJ-68284528 infusion or for 4 weeks following discontinuation of lenalidomide (whichever is later).
- •For a full list of exclusion criteria, please refer to the protocol, pg 63-81.
研究者
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