Emapalumab Prevention of CAR-T Cell Associated Toxicities
NCT ID: NCT06550141
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2024-09-18
2027-08-01
Brief Summary
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The research study involves the following study interventions:
* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)
* Axicabtagene Ciloleucel
* Emapalumab
Detailed Description
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A phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
The U.S. Food and Drug Administration (FDA) has not approved emapalumab for the participants specific disease, but it has been approved for other uses.
The U.S. FDA has approved axicabtagene ciloleucel for the participants specific disease.
This research study procedures include screening for eligibility, study treatment including collection of T cells (leukapheresis), lymphodepleting chemotherapy, treatment with emapalumab and axicabtagene ciloleucel, and follow-up evaluations.
Once study treatment is completed, the participants will be followed for up to 24 months.
It is expected that about 28 people will take part in this research study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Emapalumab
An interferon gamma (IFNγ) blocking antibody
Cyclophosphamide
Alkylating agent
Fludarabine Phosphate
Purine antagonist antimetabolite
Axicabtagene Ciloleucel
Autologous treatment
Interventions
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Emapalumab
An interferon gamma (IFNγ) blocking antibody
Cyclophosphamide
Alkylating agent
Fludarabine Phosphate
Purine antagonist antimetabolite
Axicabtagene Ciloleucel
Autologous treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Swedish Orphan Biovitrum
INDUSTRY
Marcela V. Maus, M.D.,Ph.D.
OTHER
Responsible Party
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Marcela V. Maus, M.D.,Ph.D.
Sponsor-Investigator
Principal Investigators
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Matthew Frigault, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Matthew Frigault, MD
Role: primary
Caron Jacobson, MD
Role: primary
Other Identifiers
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24-317
Identifier Type: -
Identifier Source: org_study_id