EUCTR2017-002400-26-FR进行中（未招募）1 期
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 403
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. =18 years of age.
- •2. Criterion modified per Amendment 11
- •2.1. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic a criteria
- •3. Criterion modified per Amendment 1
- •3.1. Criterion modified per Amendment 11
- •3.2. Part 1:
- •Subjects with measurable multiple myeloma who have progressed on, or could not tolerate, all available established therapies.
- •Subjects with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies:
- •Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours;
- •Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin FLC =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
- •If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%.
- •Measurable disease
- •Cohort A and Cohort B: Multiple myeloma must be measurable by central laboratory assessment:
- •. Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine Mprotein level =200 mg/24 hours; or
- •. Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) =10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
- •If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%.
- •Prior treatment
- •. Cohort A: have previously received =3 prior lines of therapy that included at least one PI, one IMiD, and an anti-CD38 monoclonal antibody, and have not been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies.
- •. Cohort B: have previously received =3 prior lines of therapy that included at least one PI, one IMiD, and an anti-CD38 monoclonal antibody, and have been exposed to T cell redirection therapies such as CAR-T or bispecific antibodies.
- •Cohorts A and B:
- •Undergone at least 1 complete cycle of treatment for each line of therapy, unless progressive disease was the best response to the line of therapy.
- •Subject must have documented evidence of progressive disease based on investigator’s determination of response by the IMWG 2016 criteria on or within 12 months of their last line of therapy. Also, subjects with documented evidence of progressive disease within the previous 6 months and who are refractory or non-responsive to their most recent line of therapy afterwards are eligible.
- •4. Criterion modified per Amendment 11
- •4.1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- •5. Criterion modified per Amendment 11
- •5.1. Pretreatment clinical laboratory values meeting the predefined criteria during the Screening Phase
- •6. Criterion modified per Amendment 10
- •6.1. Criterion modified per Amendment 11
- •Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (ß human chorionic gonadotropin [ß-hCG]) or urine.
- •. a woman is considered of childbearing potential (WOCBP) ie, fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- •7. Criterion modified per Amendment 11
- •7.1. Before the first dose of study drug:
排除标准
- •1. Criterion modified per Amendment 11
- •1.1. Prior Grade 3 CRS (Per Lee Criteria 2014) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy) or any prior GPRC5D targeting therapy
- •2. Criterion modified per Amendment 10.
- •2.1 Criterion modified per Amendment 11
- •2.2 Prior antitumor therapy as follows, prior to the first dose of study drug:
- •. Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells [CAR-T], natural killer [NK] cells) within 3 months.
- •. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less.
- •. Monoclonal antibody treatment for multiple myeloma within 21 days.
- •. Cytotoxic therapy within 21 days.
- •. Proteasome inhibitor therapy within 14 days.
- •. Immunomodulatory agent therapy within 7 days.
- •. Radiotherapy within 14 days. However, if palliative focal radiation is used, the subject is eligible irrespective of the end date of radiotherapy.
- •Part 3 only:
- •. Cohort A only: exposed to a CAR-T or T cell redirection therapy at any time.
- •. Cohort B: T cell redirection therapy within 3 months
- •3. Criterion modified per Amendment 11
- •3.1. Vaccinated with live, attenuated vaccine within 4 weeks or as recommended by the product manufacturer prior to the first dose, during treatment, or within 100 days of the last dose of talquetamab.
- •4. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- •5. Criterion modified per Amendment 11.
- •5.1. 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).
- •6. Received either of the following:
- •. An allogenic stem cell transplant within 6 months before first dose of study drug. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft versus host disease (GVHD).
- •. An autologous stem cell transplant =12 weeks before first dose of study drug
- •7. Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required.
- •8. Criterion modified per Amendment 6
- •8.1. Criterion modified per Amendment 11
- •8.2. Plasma cell leukemia (>2.0 x 10 to the 9th/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes), or primary amyloid light chain amyloidosis.
- •9. Known to be seropositive for human immunodeficiency virus or acquired immune deficiency syndrome.
- •10. Criterion modified per Amendment 11
- •10.1. Hepatitis B infection as defined according to the American Society of Clinical Oncology guidelines. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status.
- •Active Hepatitis C infection as measured by positive HCV-RNA testing. Subjects with a history of Hepatitis C virus antibody positivity must undergo HCV-RNA testing.
- •11. Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation.
- •12. Criterion modified per Amendment 11
- •12.1. Known allergies, hypersensitivity, or intolerance to talquetamab or
研究者
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