Emapalumab to Prevent CAR-T Toxicities in Large B-cell Lymphoma
This study is looking at whether a drug called emapalumab can help prevent side effects when you receive CAR-T cell therapy (axicabtagene ciloleucel) for large B-cell lymphoma. CAR-T cell therapy is a type of immunotherapy where your own immune cells are specially trained to fight cancer. Sometimes, this therapy can cause a serious side effect called cytokine release syndrome (CRS). Researchers want to see if emapalumab, which blocks a protein called interferon gamma (IFNγ), can reduce the chance of developing moderate to severe CRS. You might be able to join if you have large B-cell lymphoma that has come back or hasn't responded to previous treatments. The study will enroll about 28 people and will measure how many develop grade 2 or higher CRS within 24 months after treatment.
- Study design
- This is a Phase 2, multi-center, open-label study evaluating the safety and effectiveness of emapalumab. It plans to enroll about 28 participants.
- What's involved
- You would undergo screening, T-cell collection (leukapheresis), chemotherapy (fludarabine and cyclophosphamide), and receive emapalumab and axicabtagene ciloleucel. You will then have follow-up evaluations.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to 24 months after completing the study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06550141
Emapalumab Prevention of CAR-T Cell Associated Toxicities
Recruiting
PHASE2Ages 18+InterventionalTreatmentMarcela V. Maus, M.D.,Ph.D.Investigator-initiated
~28 participants
Updated 2025-11-14 on ClinicalTrials.gov
What's tested:EmapalumabCyclophosphamideFludarabine PhosphateAxicabtagene Ciloleucel
At a glance
Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 2+ CRS per ASTCT
Measured over Day -1 to 24 months post treatment
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Matthew Frigault, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
At least 1 measurable lesion per Lugano at time of screening.
At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy however steroids only require a 7-day washout.
At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc).
Age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate renal, hepatic, pulmonary and cardiac function defined as:
ANC ≥1000/uL
Platelet count ≥50,000/uL
Absolute lymphocyte count ≥100/uL
Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL/min
Serum ALT/AST ≤2.5 per institutional ULN
Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings
Baseline oxygen saturation \>92% on room air.
Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.
History of Richter's transformation of CLL.
Autologous stem cell transplant within 6 weeks of planned axicabtagene ciloleucel infusion.
History of allogeneic stem cell transplantation.
Presence of uncontrolled fungal, bacterial, viral, or other infection at time of screening.
Known history of acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines.
Patients should also be negative for latent Tb, CMV (NAT), EBV (NAT) and adenovirus (NAT) by PCR testing.
No evidence of active CNS disease regardless of prior CNS history.
History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage within 6 months of enrollment.
History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.
History of symptomatic pulmonary embolism within 3 months of enrollment; ongoing anticoagulation is allowed if beyond 3 months.
Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.
History of allergic reactions or severe immediate hypersensitivity reaction to any of the agents used in this study or compounds of similar chemical or biologic composition.
Females who are pregnant or breastfeeding or female or male participants who are not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel
In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
History of autoimmune disease requiring ongoing systemic immunosuppression. Steroids are allowed up to 5mg predinosine-equivalent for adrenal insufficiency.
Patients anticipated to require canakinumab, JAK inhibitors, TNF inhibitors, and tocilizumab for non-CAR-T management of baseline autoimmune/inflammatory disease at the time of emapalumab initiation.
Receipt of a BCG vaccine within 12 weeks prior to Screening.
Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screeing.
Participants who are receiving any other investigational agents for this condition.
What this trial measures
- Incidence of grade 2+ CRS per ASTCTDay -1 to 24 months post treatment
Assessed using American Society for Transplantation and Cellular Therapy (ASTCT). All participants will be monitored and assessed for grade 2+ cytokine release syndrome (CRS) for 24 months after post treatment.