A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma

Janssen - Cilag International22 个研究点分布在 7 个国家目标入组 267 人2024年7月31日

概览

阶段: 1/2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Janssen - Cilag International
入组人数: 267
试验地点: 22
主要终点: Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Part 1 (dose escalation): To identify the proposed RP2D(s) and schedule assessed to be safe for teclistamab Part 2 (dose expansion): To characterize the safety and tolerability of teclistamab at the proposed RP2D(s) Part 3 (Phase 2): To evaluate the efficacy of teclistamab at the RP2D

注册库

euclinicaltrials.eu

开始日期

2024年7月31日

结束日期

待定

最后更新

去年

研究者

发起方

Janssen - Cilag International

责任方

Principal Investigator

主要研究者

CTIS Point of Contact

Scientific

Janssen - Cilag International

入排标准

入选标准

•Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
•Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
•A female participant of childbearing potential must have a negative pregnancy test at screening
•Willing and able to adhere to the prohibitions and restrictions specified in this protocol
•Cohorts A: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received ≥ 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)

排除标准

•Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
•Prior autologous stem cell transplant ≤ 12 weeks
•Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
•The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (≤) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction ≤ 6 m, stage III-IV congestive heart failure, etc)
•Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
•Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
•Toxicities from previous anticancer therapies that have not resolved to baseline or to ≤ grade 1 (except for alopecia or peripheral neuropathy)
•Received a cumulative dose of corticosteroids equivalent to ≥ 140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
•Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
•Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence

结局指标

主要结局

Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria