NCT06830733

Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Plasma Cell

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2025-02-17
• Last updated: 2025-04-25

Locations

7 sites across 1 country: Spain