Actively Recruiting
A Phase 2 Trial of Emapalumab for Preventing CAR-T Cell Related Toxicities in Large B-cell Non-Hodgkin's Lymphoma
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2025-11-14
28
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
Marcela V. Maus, M.D.,Ph.D.
Lead Sponsor
S
Swedish Orphan Biovitrum
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research evaluates emapalumab as a preventive treatment for toxic side effects related to axicabtagene ciloleucel therapy in adults with certain types of large B-cell non-Hodgkin's lymphoma that have returned or not responded to previous treatments. This phase 2 study focuses on the safety and effectiveness of emapalumab alongside approved therapies to better manage these treatment-related complications. Participants receive several treatments in sequence: first, their T cells are collected through leukapheresis. Then, they undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days. On the day before receiving axicabtagene ciloleucel, participants get a single intravenous dose of emapalumab. Axicabtagene ciloleucel is administered once by infusion on the following day. After completing these treatments, participants are monitored for up to 24 months. Throughout the study, participants will undergo assessments to track the incidence of cytokine release syndrome (CRS) and other neurological side effects, as well as the lymphoma's response to treatment. Regular follow-up visits include evaluations of safety and effectiveness, with detailed monitoring of blood tests, physical health, and symptoms. The total participation time covers treatment and two years of follow-up to gather comprehensive outcome data.
CONDITIONS
Brief Title
Emapalumab Prevention of CAR-T Cell Associated Toxicities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months
- Adults with relapsed or refractory large B-cell lymphoma after two or more systemic therapies, including specific lymphoma types
- At least one measurable lesion at screening
- At least 2 weeks or 5 half-lives since prior systemic therapy before leukapheresis, except immune checkpoint therapy with 7-day steroid washout
- At least 3 half-lives since prior immune checkpoint molecule therapy before leukapheresis
- Age 18 years or older
- ECOG performance status 0 to 2
- Adequate kidney, liver, lung, and heart function per defined laboratory and clinical measures
- Females of childbearing potential must have a negative pregnancy test
- Ability to understand and sign informed consent
You will not qualify if you...
- History of malignancies other than nonmelanoma skin cancer or carcinoma in situ unless disease free for 3 years
- History of Richter's transformation of CLL
- Autologous stem cell transplant within 6 weeks before planned infusion
- History of allogeneic stem cell transplantation
- Uncontrolled infections at screening
- History of active hepatitis B or C infection unless cleared
- Positive testing for latent TB, CMV, EBV, or adenovirus
- Active central nervous system disease
- Recent CNS disorders such as seizures or stroke within 6 months
- Major cardiac events within 12 months before enrollment
- Symptomatic pulmonary embolism within 3 months
- Medical conditions interfering with study assessments
- Severe allergic reactions to study agents
- Pregnancy, breastfeeding, or unwillingness to use birth control
- Unlikely to complete study procedures
- Autoimmune disease requiring systemic immunosuppression except low-dose steroids
- Need for certain immune-modulating drugs at emapalumab start
- Recent BCG vaccine within 12 weeks
- Recent live vaccines within 4 weeks
- Receiving other investigational agents for this condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Approximately 6 days
Participants receive leukapheresis to collect T cells, lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, a single dose of emapalumab, and a single infusion of axicabtagene ciloleucel.
1 leukapheresis visit, 3 daily chemotherapy visits, 1 emapalumab infusion visit, and 1 CAR-T cell infusion visit
Duration - Up to 24 months
After treatment, participants are monitored for safety and treatment response with evaluations continuing for up to 24 months.
Regular follow-up visits according to study schedule
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
M
Matthew Frigault, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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