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Prevention study for Large B-cell Lymphoma
Official title Emapalumab Prevention of CAR-T Cell Associated Toxicities
ClinicalTrials.gov ID: NCT06550141
What this study is testing
What is Emapalumab?
Emapalumab is an investigational medicine, being studied as a potential treatment for large b-cell lymphoma.
Also referred to as Human anti-interferon gamma (IFNγ) monoclonal antibody, Gamifant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line...
- 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...
- At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is...
- Age 18 or older
You likely can't join if
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease...
- 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. people with history of hepatitis infection must have cleared their infection as...
See the full eligibility 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...
- 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...
- 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...
- 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 people 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...
- Ability to understand and the willingness to sign a written informed consent document.
- 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. people with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current...
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.