EUCTR2021-003747-22-ES进行中（未招募）1 期
A Phase 2 study of PHE885, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma
ovartis Farmacéutica, S.A.0 个研究点目标入组 100 人开始时间: 2022年1月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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. Written informed consent must be obtained prior to any screening procedures.
- •2. Participants must be =18 years of age at the time of informed consent form (ICF) signature.
- •3. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at screening.
- •4. Participant has a previous diagnosis of MM, based on IMWG definitions.
- •5. Participants who have failed three or more lines of therapy including failing an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an anti-CD38 agent (e.g., daratumumab, isotuximab) and have documented evidence of disease progression (IMWG criteria).
- •A minimum of 51 participants who have failed 3 therapies will be required among the 100 evaluable participants. Enrollment for participants with 4 or more lines of prior therapy will be closed after the 49th participant to meet this eligibility criteria.
- •6. Must have received = 1 cycle of treatment for each regimen unless deemed refractory to that regiment (i.e. progressive disease as the best response).
- •7. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
- •8. Must have measurable disease defined by at least 1 of the following 3 measurements as per IMWG criteria:
- •Serum M-protein = 1.0 g/dL OR
- •Urine M-protein = 200 mg/24 hours OR
- •Serum free light chain (FLC) = 100 mg/L of involved FLC provided sFLC ratio is abnormal
- •9. The participant is willing and able to adhere to the procedures and treatments outlined in the protocol.
- •10. Must have a leukapheresis product of non-mobilized cells accepted for manufacturing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Prior administration of a genetically modified cellular product, including prior BCMA CAR-T cell therapy.
- •2. Participants who have received prior BCMA-directed bi-specific antibodies or anti-BCMA antibody drug conjugate.
- •3. Hypersensitivity to any product (including its ingredients) to be given to the participant as per the study protocol (e.g., PHE885, tocilizumab and lymphodepleting agents).
- •4. Prior autologous SCT within 3 months prior to signing informed consent or allogeneic SCT within 3 months prior to signing informed consent.
- •5. Active Graft-versus-Host Disease (GVHD), grade 2-4 according to the Mount Sinai GvHD International Consortium criteria or requiring systemic treatment.
- •6. Plasma cell leukemia and other plasmacytoid disorders, non-secretory myeloma without other evidence of measurable disease.
- •7. POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- •8. Active CNS involvement by malignancy. Participants whose CNS involvement was treated with resolved symptoms, provided that local treatment was > 4 weeks before enrollment, are eligible.
- •9. Participants with active neurological auto immune or inflammatory disorders (e.g., Guillain-Barre Syndrome, Amyotrophic Lateral Sclerosis).
- •10. Participants with Grade = 3 neuropathy, or residual non-hematologic effects of Grade = 2 from previous therapy (excluding alopecia).
- •11. Chemotherapy, small molecule targeted antineoplastics, or any concomitant anti-cancer therapies (other than protocol allowed LD chemotherapy) within 2 weeks prior to apheresis or prior to PHE885 injection.
- •12. For participants that received prior antibodies (e.g., daratumumab, isotuximab, elotuzumab) the washout period is 3 weeks prior to apheresis collection.
- •13. Radiotherapy within 2 weeks prior to enrollment except localized radiation therapy for lytic bone lesions or plasmacytomas.
- •14. Investigational medicinal product within the 4 weeks prior to screening or within 5-half-lives of the investigational product, whichever is longer. Note: Investigational therapies must not be used at any time while on study until the first progression following PHE885 injection.
- •15. Participants receiving systemic steroid therapy or other immunosuppressive drugs unless the conditions outlined in the protocol are met.
- •16. Previous or concurrent malignancy with the following exceptions:
- •Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
- •In situ carcinoma treated curativel
- •A primary malignancy which has been completely resected and in complete remission for = 3 years.
- •17. Impaired cardiac function or clinically significant cardiac disease, including any of the conditions outlined in the protocol.
- •18. Inadequate organ function during screening (i.e., within 56 days before the first dose of study treatment) as outlined in the protocol.
- •19. Presence of active hepatitis B or C as indicated by serology.
- •20. Human immunodeficiency virus (HIV) positivity as indicated by serology.
- •21. Clinically significant active infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA, etc.).
- •22. Use of any live vaccines against infectious disease within 6 weeks of PHE885 injection.
- •23. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •24. Pregnant or nursing (lactating) women. NOTE: Women
研究者
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