Actively Recruiting
Emapalumab Prevention of CAR-T Cell Associated Toxicities
Led by Marcela V. Maus, M.D.,Ph.D. · Updated on 2025-11-14
28
Participants Needed
2
Research Sites
149 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 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
CONDITIONS
Official 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 relapsed within 12 months of first-line treatment
- Adults with relapsed or refractory large B-cell lymphoma after two or more systemic therapies, including various lymphoma subtypes
- 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 specific washout periods
- At least 3 half-lives since prior immune checkpoint molecule therapy before leukapheresis
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate kidney, liver, lung, and heart function as defined by specific lab and clinical criteria
- Negative pregnancy test for females of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancies unless disease-free for at least 3 years, except certain skin cancers and carcinoma in situ
- History of Richter's transformation of chronic lymphocytic leukemia
- Autologous stem cell transplant within 6 weeks before planned infusion
- History of allogeneic stem cell transplantation
- Uncontrolled infections at screening
- Active or unresolved hepatitis B or C infection
- Positive tests for latent tuberculosis, CMV, EBV, or adenovirus
- Active central nervous system disease or recent CNS disorders
- Significant cardiac events within 12 months before enrollment
- Recent symptomatic pulmonary embolism within 3 months
- Medical conditions interfering with study safety or efficacy assessment
- Allergic reactions to study agents or similar compounds
- Pregnancy or breastfeeding or unwillingness to use birth control during and after study
- Inability or unwillingness to complete protocol visits or comply with study
- Autoimmune disease requiring systemic immunosuppression (with some steroid allowance)
- Anticipated need for certain immunosuppressive drugs at emapalumab start
- Recent BCG or live vaccines
- Use of other investigational agents for this condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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