Emapalumab Prevention of CAR-T Cell Associated Toxicities

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Marcela V. Maus, M.D.,Ph.D.
Study ID
NCT06550141
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Sep 18, 2024
Status verified
Nov 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Emapalumab
    Leukapheresis will happen within approximately 5 days of eligibility confirmation. Emapalumab is given as a single dose on Day -1 by intravenous infusion over about 1 hour. Lymphodepleting Chemotherapy with cyclophosphamide and fludarabine will occur once a day for 3 days (Days -5 through Day -3) by intravenous infusion over about 2-4 hours. Axicabtagene ciloleucel will be given once on Day 0 by intravenous infusion over about 30 minutes.

Primary Outcome Measure

Incidence of grade 2+ CRS per ASTCT [ Time Frame: Day -1 to 24 months post treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Caron Jacobson, MD
[email protected]
(617)-632-5847
Massachusetts General HospitalBostonMassachusetts02114
Matthew Frigault, MD
[email protected]
617-643-6175
Matthew Frigault, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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