NCT07509086

IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia

A Clinical Study Evaluating the Safety and Efficacy of IL-15-armored Novel CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.

Detailed description

This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored CAR-T therapy in subjects with relapsed or refractory (R/R) multiple myeloma (MM) and plasma cell leukemia (PCL). Subjects with persistent measurable residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status are also eligible. IL-15-armored CAR-T cells are autologous T lymphocytes genetically engineered to express a chimeric antigen receptor along with IL-15. The co-expression of IL-15 is intended to enhance in vivo expansion, persistence, and anti-tumor activity. Subjects will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepletion prior to infusion. Bridging therapy is permitted at the investigator's discretion, and radiotherapy is allowed before infusion for subjects with extramedullary disease. After infusion, the efficacy and safety will be evaluated by the investigators. Exploratory Objectives and Correlative Studies: In addition to the primary efficacy and safety evaluations, exploratory analyses will be conducted to investigate clinical, biological, and treatment-related factors associated with treatment response and severe toxicity, with the aim of developing predictive models. Multi-omics approaches, including single-cell sequencing, bulk RNA sequencing, and spatial transcriptomics, will be employed to characterize the dynamics of the tumor microenvironment. Circulating tumor DNA (ctDNA) will be longitudinally collected from baseline through post-infusion follow-up. The associations between ctDNA dynamics and clinical outcomes will be assessed. The clinical efficacy and biological mechanisms of radiotherapy (including site-directed radiotherapy and low-dose intestinal irradiation) in combination with CAR-T cell therapy will also be explored.

Conditions

• Relapsed/Refractory Multiple Myeloma
• Plasma Cell Leukemia (PCL)

Interventions

Type	Name	Description
BIOLOGICAL	IL-15-armored CAR-T cells	BCMA-targeted: 1.0/1.5/2.0 × 10\^6 CAR-T cells; CD19/BCMA dual-targeted: 1.0/1.5/2.0 × 10\^6 CAR-T cells; GPRC5D-targeted: 1.0/2.0/3.0 × 10\^6 CAR-T cells.

Timeline

• Start date: 2025-12-29
• Primary completion: 2028-07-15
• Completion: 2029-07-15
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: China