AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Emapalumab Prevention of CAR-T Cell Associated Toxicities

RecruitingPhase 2Ages 18 Years - anyAllMarcela V. Maus, M.D.,Ph.D.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 or Lisocabtagene Maraleucel * Emapalumab

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. * 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 โ‰ฅ1000/uL * Platelet count โ‰ฅ50,000/uL * Absolute lymphocyte count โ‰ฅ100/uL * Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) โ‰ฅ 30 mL/min * Serum ALT/AST โ‰ค2.5 per institutional ULN * Total bilirubin โ‰ค1.5 mg/dl, except in subjects with Gilbert's syndrome. * Cardiac ejection fraction โ‰ฅ 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. * Autologous stem cell transplant within 6 weeks of planned CAR-T 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 CAR-T * 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. * 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. * 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.
๐Ÿ’Š

What it tests

  • Emapalumab
  • Cyclophosphamide
  • Fludarabine Phosphate
  • Axicabtagene Ciloleucel
  • Dexamethasone
๐Ÿ“

Where

2 sites
Massachusetts General Hospital
Boston, United States
Dana-Farber Cancer Institute
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy