2023-506587-13-00招募中2 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 CARTITUDE-2
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- MRD negative rate (10-5 threshold) as defined by the International Myeloma Working Group (IMWG) criteria using next generation sequencing (NGS) or next generation flow (NGF)
研究概览
简要总结
To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Cohort A: -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)
- •Cohort B: -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)
- •Cohort C: -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
- •Cohort D: -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 local REMS, whichever is more stringent, as applicable in their region.
- •Cohort E: -Measurable disease at Screening - Documented diagnosis of MM according to IMWG criteria -Labs as specified in the protocol
- •Cohort F: - Documented new diagnosis of multiple myeloma according to IMWG diagnostic criteria. - Multiple myeloma classified as standard risk per International Staging System (ISS) stage I or II disease criteria - Received initial therapy as specified in protocol. Acceptable combinations include: a. daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd) or b. daratumumab, lenalidomide and dexamethasone (D-Rd) or c. a carfilzomib-based triplet or quadruplet regimen - Patient must have a documented efficacy response of VGPR or better, without Progressive Disease prior to enrollment, as assessed per IMWG 2016 criteria. - ECOG Performance Status grade of 0 or
- •For a full list of inclusion criteria, please refer to the protocol
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).
- •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). -Contraindications, known life threatening allergies, hypersensitivity, or intolerance to cyclophosphamide, fludarabine, lenalidomide, or JNJ68284528 or its excipients, including DMSO (refer to Investigator's Brochure).
- •Cohort E: 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).
- •Cohort F: - 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
结局指标
主要结局
MRD negative rate (10-5 threshold) as defined by the International Myeloma Working Group (IMWG) criteria using next generation sequencing (NGS) or next generation flow (NGF)
MRD negative rate (10-5 threshold) as defined by the International Myeloma Working Group (IMWG) criteria using next generation sequencing (NGS) or next generation flow (NGF)
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International
研究点 (11)
Loading locations...
相似试验
招募中
3 期
Extension Study for Participants in Studies That Include Pembrolizumab2022-501254-10-00Merck Sharp & Dohme LLC1,133
招募中
1 期
A Study of YL201 in Combination With Toripalimab and With or Without Cisplatin in Nasopharyngeal Carcinoma.NCT07258979MediLink Therapeutics (Suzhou) Co., Ltd.202
招募中
2 期
Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful BiomarkersAdvanced Breast CancerNCT07259226UNICANCER400
已完成
2 期
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and
Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin
Lymphoma (JCAR017-FOL-001)jRCT1080225154Bristol-Myers Squibb K.K.18
已完成
2 期
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trial to Evaluate the Efficacy andSafety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-HodgkinLymphomaJPRN-jRCT1080225154Bristol-Myers Squibb K.K.18