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 (GEM-PLASMACAR)

NCT06830733 Phase 2 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Fundacion Clinic per a la Recerca Biomédica
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	25
Start date	2025-04
Completion	2027-12

Conditions

• Leukemia, Plasma Cell

Interventions

• ARI0002h

Primary outcomes

• Overall response rate (ORR) — 3 months after the first infusion
  Overall response rate (ORR) during the initial 3 months after the first infusion (at least presenting a partial response according to the International Myeloma Working Group criteria).
• Rate of patients who develop cytokine release syndrome and/or neurological toxicity — 30 days after CARTBCMA administration
  Rate of patients who develop cytokine release syndrome and/or neurological toxicity in the first 30 days after CARTBCMA administration, according to the criteria and grading defined in the international consensus document

Countries

Spain