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Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia
Sponsor: Fundacion Clinic per a la Recerca Biomédica
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.
Official title: Phase II, Multicenter, Open-label, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of ARI0002h, a CAR-T Cell Against BCMA, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2025-04
Completion Date
2027-12
Last Updated
2025-04-25
Healthy Volunteers
No
Conditions
Interventions
ARI0002h
* 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.
Locations (7)
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