NCT05850286

A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities

VRd-based Regimen Combined With CART-ASCT-CART2 as First-line Therapy for Newly Diagnosed Multiple Myeloma Patients With P53 Abnormalities：a Prospective, One-arm, Single-center Phase II Study

• 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(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities.

Detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with the VRd (short for Bortezomib, Lenalidomide, Dexamethasone)-based regimen in combination with the CART-ASCT-CART2 in newly diagnosed multiple myeloma patients with P53 gene abnormalities. Patients received 3 courses of induction therapy with VRd-based regimen followed by a first infusion of CAR-T cells. Patients then received 3 courses of consolidation therapy, followed by ASCT and second infusion of CAR-T cells. R maintenance therapy starts on day 100 after ASCT

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	anti-BCMA CAR-T	Autologous BCMA-directed CAR-T cells, double infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg.
DRUG	VRD-based Regimen	Bortezomib, Lenalidomide and Dexamethasone

Timeline

• Start date: 2023-04-21
• Primary completion: 2025-10-01
• Completion: 2027-04-01
• First posted: 2023-05-09
• Last updated: 2025-08-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study