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Recruiting

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma - CC-98633-MM-001

Actualizada: 1 junio, 2021   |   ClinicalTrials.gov

Juno Therapeutics y Celgene son subsidiarias propiedad de Bristol-Myers Squibb Company

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 10

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: CC-98633
Biological: CC-98633

Criterios clave de elegibilidad

Inclusion Criteria: 1. Age ≥ 18 years. 2. Signed written informed consent prior to any study procedure. 3. Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least 3 prior antimyeloma treatment regimens. Subjects must have documented progressive disease during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent anti-myeloma treatment regimen afterwards will be also eligible. Subjects must have previously received all of the following therapies: 1. Autologous stem cell transplant 2. A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination 3. Anti-CD38 (eg, daratumumab), either alone or combination 4. Measurable disease 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function Exclusion Criteria: 1. Known active or history of central nervous system (CNS) involvement of MM 2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis 3. Prior treatment with CAR T-cell or another genetically modified T-cell therapy 4. Prior treatment with investigational therapy directed at BCMA 5. Uncontrolled or active infection 6. Active autoimmune disease requiring immunosuppressive therapy 7. History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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