Trial NCT06550141
Emapalumab Prevention of CAR-T Cell Associated Toxicities
- Phase
- Phase 2
- Sponsor
- Marcela V. Maus, M.D.,Ph.D.
- Conditions
- Large B-cell Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Primary Mediastinal Large B-cell Lymphoma; High-grade B-cell Lymphoma; Follicular Lymphoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
* 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/minRenal
* Serum ALT/AST ≤2.5 per institutional ULNHepatic
* 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 findingsCardiac
* 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.Prior malignancy
* 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.Brain metastases
* 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-TPregnancy
* 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.
Restrictions found (7)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalinclusion
LVEF >= 40%
Show in the text - HepaticConditionalinclusion
ALT/AST <= 2.5x ULN
Show in the text - Performance statusConditionalinclusion
ECOG 0-2
Show in the text - PregnancyOutrightexclusionShow in the text
- Prior malignancyConditionalexclusion
disease free for at least 3 years
Show in the text - RenalConditionalinclusion
CrCl >= 30 mL/min
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County