NCT05870917

A Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Primary Plasma Cell Leukemia

A Prospective, Single-center, Phase II Study of VRD-based Regimen Combined With CART-ASCT-CART2 Treatment in Patients With Newly Diagosed Primary Plasma Cell Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) combined with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia.

Detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with VRD-based Regimen (Bortezomib, Lenalidomide and Dexamethasone) in combination with CART-ASCT-CART2 in Chinese patients with newly diagnosed primary plasma cell leukemia. Patients receive 3 cycles of induction therapy with VRD-based regimen followed by the first infusion of CAR-T cells. Patients then received 3 cycles of VR-based consolidation therapy, followed by ASCT and the second infusion of CAR-T cells. And R or R maintenance starts on day 100 after ASCT.

Conditions

• Plasma Cell Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA CAR-T	Autologous BCMA-directed CAR-T cells, the double infusion intravenously at a target dose of (2-4)±20％ x 10\^6 anti-BCMA CAR+T cells/kg respectively

Timeline

• Start date: 2023-04-25
• Primary completion: 2026-06-01
• Completion: 2027-04-01
• First posted: 2023-05-23
• Last updated: 2026-03-02

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study