EUCTR2018-000121-32-FR进行中（未招募）1 期
A Phase 1b-2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA 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
- 110
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
入选标准
- •1. 18 years of age.
- •2.Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- •3.Measurable disease at Screening as defined by any of the following:
- •- Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours; or
- •- Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain greater than or equal to 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- •4.Received at least 3 prior multiple myeloma treatment regimens or are double refractory to an IMiD and PI (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single regimen.
- •-Undergone at least 1 complete cycle of treatment for each regimen, unless PD was the best response to the regimen.
- •5. Received as part of previous therapy a PI, an IMiD, and an anti-CD38 antibody (prior exposure can be from different monotherapy or combination regimens).
- •6. Subject must have documented evidence of progressive disease based on investigator’s determination of response by the IMWG criteria on or within 12 months of their last regimen. Confirmation may be from either central or local testing. Also, subjects with documented evidence of progressive disease (as above)
- •within the previous 6 months and who are refractory or non-responsive to their most recent line of treatment afterwards are eligible.
- •7. ECOG Performance Status grade of 0 or 1
- •8. Clinical laboratory values as specified in the protocol
- •9. Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of cyclophosphamide and fludarabine using a highly sensitive serum pregnancy test (ß human chorionic gonadotropin [ß-hCG]).
- •10. When a woman is of childbearing potential the following are required:
- •-Subject must agree to practice a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly) and agree to remain on a highly effective method of contraception from the time of signing the informed consent form (ICF) until at least 100 days after receiving a JNJ-68284528 infusion.
- •-Examples of highly effective contraceptives include:
- •- user-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone-releasing system; 3) vasectomized partner;
- •- user-dependent methods: 1) combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: oral or intravaginal or transdermal; 2) progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable)
- •In addition to the highly effective method of contraception a man:
- •-Who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from the time of signing the ICF until
排除标准
- •1. Prior treatment with CAR-T therapy directed at any target.
- •2. Any therapy that is targeted to BCMA.
- •3. Diagnosed or treated for invasive malignancy other than multiple myeloma, except:
- •-Malignancy treated with curative intent and with no known active disease present for greater than or equal to 2 years before enrollment; or
- •-Adequately treated non-melanoma skin cancer without evidence of disease.
- •4. Prior antitumor therapy as follows, prior to apheresis:
- •-Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 14 days or at least 5 half lives, whichever is less
- •-Monoclonal antibody treatment for multiple myeloma within 21 days.
- •-Cytotoxic therapy within 14 days.
- •-Proteasome inhibitor therapy within 14 days.
- •-Immunomodulatory agent therapy within 7 days.
- •-Radiotherapy within 14 days. However, if the radiation portal covered less than or equal to 5% of the bone marrow reserve, the subject is eligible irrespective of the end date of radiotherapy.
- •5. Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
- •6. The following cardiac conditions:
- •-New York Heart Association (NYHA) stage III or IV congestive heart failure
- •-Myocardial infarction or coronary artery bypass graft (CABG) less than or equal to 6 months prior to enrollment
- •-History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- •-History of severe non-ischemic cardiomyopathy
- •-Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal to 8 weeks of apheresis).
- •7. Received a cumulative dose of corticosteroids equivalent to =70 mg of prednisone within the 7 days prior to apheresis
- •8. Received either of the following:
- •-An allogenic stem cell transplant within 6 months before apheresis. 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 less than or equal to 12 weeks before apheresis
- •9. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- •10. Stroke or seizure within 6 months of signing ICF.
- •11. Plasma cell leukemia at the time of screening (>2.0 x 109/L plasma cells by standard differential), Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
- •12. Seropositive for human immunodeficiency virus (HIV).
- •13. Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis.
- •14. Hepatitis B infection as defined in the protocol. In the event the
- •infection status is unclear, quantitative levels are necessary to determin
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