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NOT YET RECRUITING
NCT06830733
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

GENETIC

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