Can a new drug tame CAR-T's dangerous side effects?
NCT ID NCT06550141
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether emapalumab, a drug that blocks a protein called interferon gamma, can prevent severe cytokine release syndrome (CRS) in patients receiving CAR-T cell therapy for certain types of non-Hodgkin lymphoma. About 28 adults with relapsed or refractory large B-cell lymphoma will receive emapalumab alongside standard CAR-T treatment. The main goal is to see if this reduces the rate of grade 2 or higher CRS, a common and serious side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Emapalumab (a drug that blocks interferon gamma, also known as Gamifant)
- What this could lead to
- If it works, this could make CAR-T cell therapy safer by reducing severe inflammatory side effects, allowing more patients to benefit from this cancer treatment.
- What could go wrong
- This is a small, early-phase trial with only 28 participants, so results may not apply broadly. Emapalumab might not effectively prevent toxicities or could introduce new risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
NOT_YET_RECRUITINGBoston, Massachusetts, 02215, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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