Study Summary
Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL). The study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months. The primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.
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ARI0002hGENETIC
* Treatment with ARI0002h cells
* Other names: CARTBCMA\_J22.9-h:CD8TM:4-1BB:CD3. Adult differentiated autologous T cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory domain and the CD3z signalling domain that has been humanized.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Hospital Marqués de Valdecilla | Santander | Cantabria | Spain |
| Clínica Universitaria de Navarra | Madrid | Madrid | Spain |
| Hospital 12 de Octubre | Madrid | Madrid | Spain |
| Hospital Universitario Virgen de la Arrixaca | Murcia | Murcia | Spain |
| Clínica Universitaria de Navarra | Pamplona | Navarre | Spain |
| Complejo Asistencial Universitario de Salamanca | Salamanca | Salamanca | Spain |
| Hospital Clinic Barcelona | Barcelona | Spain |