NCT06550141

Emapalumab Prevention of CAR-T Cell Associated Toxicities

A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL). The research study involves the following study interventions: * Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy) * Axicabtagene Ciloleucel * Emapalumab

Detailed description

This is a phase 2 multi-center, open label study that is evaluating the safety and efficacy of emapalumab in preventing toxicities associated with axicabtagene ciloleucel in subjects with second- or third-line large B-cell non-Hodgkin's lymphoma. A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved emapalumab for the participants specific disease, but it has been approved for other uses. The U.S. FDA has approved axicabtagene ciloleucel for the participants specific disease. This research study procedures include screening for eligibility, study treatment including collection of T cells (leukapheresis), lymphodepleting chemotherapy, treatment with emapalumab and axicabtagene ciloleucel, and follow-up evaluations. Once study treatment is completed, the participants will be followed for up to 24 months. It is expected that about 28 people will take part in this research study.

Conditions

• Large B-cell Lymphoma
• Relapsed Non-Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma
• Primary Mediastinal Large B-cell Lymphoma
• High-grade B-cell Lymphoma
• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Emapalumab	An interferon gamma (IFNγ) blocking antibody
DRUG	Cyclophosphamide	Alkylating agent
DRUG	Fludarabine Phosphate	Purine antagonist antimetabolite
DRUG	Axicabtagene Ciloleucel	Autologous treatment

Timeline

• Start date: 2024-09-18
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2024-08-12
• Last updated: 2025-11-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study