EUCTR2018-004124-10-NL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
- 171
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
- •-For subjects with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria.
- •-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
- •-women of childbearing potential must follow the contraception criteria outlined in the local global REVLIMID® pregnancy prevention program or equivalent local Risk Evaluation and Mitigation Strategy (REMS), whichever is more stringent, as applicable in their region.
- •-Men should agree to practice contraception according to and for the time frame specified in the local global REVLIMID® pregnancy prevention program or equivalent localREMS, whichever is more stringent, as applicable in their region.
- •-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;
- •-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
- •For participants that have received 1 cycle of anti-myeloma therapy prior to enrollment, measurable disease must be assessed by local laboratory on the most recent evaluation prior to the start of the anti-myeloma therapy.
- •-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
- •-Not considered candidate
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
- •- Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, or JNJ-68284528 or its excipients, including DMSO (refer to Investigator’s Brochure).
- •-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).
- •-Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, lenalidomide, or JNJ-68284528 or its
- •excipients, including DMSO (refer to Investigator’s Brochure).
- •Contraindications, known life threatening allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies or human proteins, cyclophosphamide, fludarabine, lenalidomide, daratumumab,
- •bortezomib, dexamethasone, or JNJ-68284528 excipients, including DMSO.
- •-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, or until 3 months after daratumumab (whichever is later).
- •-Plans to father a child while enrolled in this study until: 1 year after receiving a JNJ-68284528 infusion, or for 4 weeks following discontinuation of lenalidomide, or until 3 months after daratumumab (whichever is later).
- •- Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study.
- •- Prior therapy, prior to apheresis
- •- Received a cumulative dose of corticosteroids equivalent to =70 mg of prednisone within the 7 days prior to apheresis
- •- Ongoing toxicity from previous anticancer therapy must have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- •- Major surgery within 2 weeks prior to apheresis, or surgery planned after apheresis up to 2 weeks after cilta-cel administration.
- •For a full list of exclusion criteria, please refer to the protocol
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