NCT07581704招募中1 期
Impact of Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
Christopher Strouse1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
This is a single center, single arm Phase Ib study with expansion cohort designed to establish the safety and physiologic effects of sirolimus pre-conditioning followed by T-cell engaging bispecific antibody therapy.
详细描述
This is a Phase Ib trial with expansion cohort to assess the safety and estimate the preliminary efficacy of sirolimus pre-conditioning prior to treatment with a T-cell engaging bispecific antibody in patients with relapsed / refractory multiple myeloma previously exposed to T-cell engager therapy. Following Phase Ib, the study will enroll an expansion cohort to test the hypothesis that sirolimus pre-conditioning will result in an increase in the Teffector: Texhausted -cell ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Willingness and ability to provide signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Aged 18 years of older.
- •Diagnosis with multiple myeloma, per IMWG Consensus Criteria.20
- •Planned for treatment with teclistamab, or talquetamab per standard of care, label indications.15
- •Prior exposure to any of the following types of T-cell engaging therapies.
- •Anti-BCMA x CD3 bispecific antibody (for example: teclistamab, elranatamab)
- •Anti-GPRC5d x CD3 bispecific antibody (for example: talquetamab)
- •Anti-GPRC5d x CD3 x CD38 trispecific antibody
- •Anti-BCMA x CD3 x CD38 trispecific antibody
- •Anti-BCMA x CD3 x GPRC5d trispecific antibody
- •Anti-BCMA chimeric antigen T-cell (for example: idecabtagene vicleucel, ciltacabtagene autoleucel)
- •Anti-FcRL5 x CD3 bispecific antibody
- •Required clinical laboratory values during screening phase
- •Hematologic Parameters Hemoglobin ≥7.0 g/dL; Platelets ≥25 x 109/L; Absolute Lymphocyte Count ≥0.2 x 109/L
- •Chemistries AST/ALT < 5 x the ULN; Total Bilirubin < 3 x the ULN
- •Ability to take oral medication and be willing to adhere to the sirolimus pre-conditioning regimen.
- •ECOG performance status of 0, 1, or 2 (KPS of >50).
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner per section5.
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Participants whose multiple myeloma is progressing at a rapid pace requiring immediate anti-myeloma therapy per assessment by the principal investigator or enrolling investigator are excluded.
- •Excluded concomitant medication exposures:
- •Exposure to corticosteroids within 1 week of treatment start
- •Exposure to calcineurin inhibitor or mTOR inhibitors (tacrolimus, everolimus, temsirolimus, sirolimus)
- •Immunomodulatory monoclonal antibodies targeting tumor necrosis factor alpha (e.g. infliximab), interleukin 6 (e.g. siltuximab),
- •Janus kinase inhibitors (e.g. ruxolitinib)
- •Any other investigational drug within 28 days
- •History of allogeneic hematopoietic cell transplantation.
- •Excluded concurrent medical conditions:
- •Active uncontrolled infection within 7 days prior to treatment start
- •Uncontrolled thrombotic event within 3 months of treatment start
- •Acute myocardial infarction or acute coronary syndrome within 6 months of start of treatment
- •Uncontrolled inflammatory bowel disease
- •Active hepatitis B virus, hepatitis C virus, or Human Immunodeficiency Virus infection
- •Uncontrolled rheumatologic conditions
- •Use of ACE-inhibitor therapy within 1 week of treatment start
- •Patients found to be taking ace-inhibitor therapy during screening can be included if the ace-inhibitor is substituted for an angiotensin receptor blocking agent. (https://drug-interactions.medicine.iu.edu/main-table)
- •CYP3A4/p-gp inhibitors and inducers for 7 days prior to sirolimus doses and 7 days after sirolimus doses(see appendix A for list)
- •Any other current active malignancy or history of metastatic malignancy that has the potential to interfere with the safety or efficacy assessment of the investigational intervention
- •Pregnancy or lactation.
- •Known allergic reactions to study agent (sirolimus).
研究者
Christopher Strouse
Clinical Assistant Professor
University of Iowa
研究点 (1)
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