NL-OMON53500尚未招募不适用
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants with Relapsed or Refractory Multiple Myeloma - 79635322MMY1001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) >=18 years of age (or the legal age of consent in the jurisdiction in
- •which the study is taking place) at the time of informed consent.
- •2) Have documented initial diagnosis of multiple myeloma according to
- •IMWG diagnostic criteria (Appendix 10.9)
- •3) Have relapsed or refractory disease and have been treated with a
- •proteasome inhibitor, IMiD agent, and an anti-CD38-based therapy for
- •the treatment of MM
- •4) Have measurable disease at screening as defined by at least 1 of the
- •a. Serum M-protein level >=0.5 g/dL; or
- •b. Urine M-protein level >=200 mg/24 hours; or
- •c. Light chain multiple myeloma: Serum Ig FLC >=10 mg/dL and abnormal
- •serum Ig kappa lambda FLC ratio.
- •d. For participants without measurable disease in the serum, urine, or
- •involved FLC, presence of plasmacytomas (>=2 cm).
- •5) Clinical laboratory values meeting the following criteria prior to
- •treatment (see protocol pages 32 - 33)
- •6) Must have an ECOG status of 0 or 1
- •7) A female participant of childbearing potential must have a negative
- •XML File Identifier: DFqXJtcO1rjdPE99rDEh/hCEz3s=
- •highly sensitive serum ß hCG test at screening and a negative urine or
- •serum pregnancy test within 72 hours before the start of study
- •treatment administration and must agree to further serum or urine
- •pregnancy tests during the study
- •8) A female participant must be
- •a. Not of childbearing potential, or
- •b. Of childbearing potential and practicing at least 1 highly effective
- •method of contraception and agrees to remain on a highly effective
- •method while receiving study drug and until 6 months after last dose.
- •The investigator should evaluate the potential for contraceptive method
- •failure (eg, noncompliance, recently initiated) in relationship to the first
- •dose of study drug.
- •Note: If a female participant becomes of childbearing potential after the
- •start of the study, the female participant must comply with (b.).
- •9) A female participant must agree not to donate eggs (ova, oocytes) or
- •freeze for future use for the purposes of assisted reproduction during
- •the study and for a period of 6 months after last dose of study
- •treatment. Female participants should consider preservation of eggs
- •prior to study treatment as anticancer treatments may impair fertility
- •10) A male participant must wear a condom when engaging in any
- •activity that allows for passage of ejaculate to another person during the
- •study and for 3 months after receiving the last dose of study treatment.
- •If partner is a female person of childbearing potential, the male
- •participant must use condom (with or without spermicide) and the
- •partner must also be practicing a highly effective method of
- •contraception (see Appendix 10.5). A male participant who is
- •vasectomized must still use a condom (with or without spermicide), but
- •the partner is not required to use contraception.
- •11) A male participant must agree not to donate sperm for the purpose
- •of reproduction during the study and for a minimum of 3 months after
- •receiving the last dose of study drug. Male participants should consider
- 另有 6 项未显示
排除标准
- •1) Central nervous system involvement or clinical signs of meningeal
- •involvement of multiple myeloma. If either is suspected, whole brain
- •MRI and lumbar cytology are required during screening
- •2) Active plasma cell leukemia, Waldenström's macroglobulinemia,
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, Mprotein,
- •and skin changes), or primary light chain amyloidosis.
- •3) Pulmonary compromise requiring supplemental oxygen used to
- •maintain adequate oxygenation
- •4) Any serious underlying medical conditions, such as:
- •a. Evidence of active viral, bacterial, or systemic
- •fungal infection requiring ongoing antiviral, antibacterial, or antifungal
- •b. Active autoimmune disease requiring systemic immunosuppressive
- •therapy within 6 months before start of study treatment. EXCEPTION:
- •Participants with vitiligo, type I diabetes, and prior autoimmune
- •thyroiditis that is currently euthyroid based on clinical symptoms and
- •laboratory testing are eligible regardless of when these conditions were
- •c. Disabling psychiatric conditions, substance abuse (eg, alcohol or drug
- •abuse), severe dementia, or altered mental status
- •d. Any other issue that would impair the ability of the participant to
- •receive or tolerate the planned treatment at the investigational site, to
- •understand the informed consent, or any condition for which, in the
- •opinion of the investigator, participation would not be in the best
- •interest of the participant (eg, compromise the well-being of the
- •participant) or that could prevent, limit, or confound the protocolspecified
- •assessments.
- •5) Have a prior or concurrent second malignancy (other than the disease
- •under study) which natural history or treatment is likely to interfere
- •with any study endpoints of safety or the efficacy of the study
- •treatment(s)
- •6) History of stroke or seizure within 6 months prior to the first dose of
- •study treatment
- •7) History of any of the following cardiac conditions
- •a. New York Heart Association stage III or IV congestive heart failure.
- •b. Myocardial infarction, unstable angina, or coronary artery bypass graft
- •<=6 months prior to enrollment.
- •c. History of clinically significant ventricular arrhythmia or unexplained
- •syncope not believed to be vasovagal in nature or due to dehydration.
- •d. History of severe nonischemic cardiomyopathy.
- •e. Screening 12-lead triplicate ECG showing an average baseline QTc interval of
- •8) Known allergies, hypersensitivity, or intolerance to excipients of JNJ-
- •Prior/Concomitant Therapy or Clinical Study Experience
- •9) Prior antitumor therapy as follows, in the specified time frame prior to
- •the first dose of study treatment:
- •a. Targeted therapy, epigenetic therapy, mAb treatment, or treatment
- •with an investigational drug or an invasive investigational medical
- •device within 21 days or at least 5 half-lives, whichever is less.
- •b. Gene-modified adoptive cell therapy (eg, CAR modified T cells, natural
- •killer cells) within 90 days.
- •c. Prior treatment with CD3-redirecting therapy within 21 days prior to
- •first dose of study treatment.
- 另有 6 项未显示
研究者
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