A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Matthew Frigault, MD
MFRIGAULT@partners.org
(617) 643-6175
Time Frame
Start Date: 2024-09-18
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 28
Treatments
Experimental: 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.
Sponsors
Leads: Marcela V. Maus, M.D.,Ph.D.
Collaborators: Swedish Orphan Biovitrum

This content was sourced from clinicaltrials.gov