Actively Recruiting
Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Led by CytoAgents, Inc. · Updated on 2026-04-17
54
Participants Needed
6
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy. The first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.
CONDITIONS
Official Title
Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Have undergone leukapheresis and are scheduled to receive CD19-directed CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) for DLBCL without corticosteroid prophylaxis for CRS and/or ICANS.
- Have relapsed or refractory DLBCL after at least one prior line of systemic therapy.
- Meet all institutional criteria for CAR T-cell therapy.
- Have adequate organ function including: creatinine clearance ≥ 60 mL/min, liver enzymes ≤ 2.5 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit of normal, left ventricular ejection fraction ≥ 40%, platelets ≥ 50,000/mm3, neutrophils > 1000/µL, lymphocytes > 100/µL.
- Have measurable lymphoma disease sufficient for assessment by Lugano Criteria.
- Have an Eastern Cooperative Oncology Group performance status of 0 to 1.
- Female participants of childbearing potential and all male participants agree to use approved birth control during the study and for 30 days after.
- Are willing to provide informed consent or have a legal representative do so on their behalf.
You will not qualify if you...
- Received cytotoxic chemotherapy within 14 days before leukapheresis.
- Have clinically significant malabsorption syndromes or swallowing difficulties not controlled by medication.
- Have grade 2 or higher electrolyte imbalances including potassium < 3.0 or > 5.5 mmol/L, sodium < 130 or > 150 mmol/L, calcium < 8.0 or > 11.5 mg/dL, magnesium < 0.5 or > 1.23 mmol/L.
- Have clinically significant ECG abnormalities, including QTcF > 470 msec, conduction block disorders, or arrhythmias.
- Have a history of significant arrhythmias or require therapeutic anticoagulation or antiplatelet treatment.
- Have active cardiovascular disease including recent stroke, myocardial infarction, unstable angina, or severe heart failure (NYHA Class III or higher).
- Have uncontrolled thromboembolic events or recent severe hemorrhage within 6 months.
- Have a known bleeding disorder.
- Require ongoing therapeutic anticoagulant, antiplatelet, or fibrinolytic therapy (except low molecular weight heparin prophylaxis).
- Have systolic blood pressure below 100 mmHg.
- Have autoimmune disease or graft versus host disease requiring immunosuppressive therapy within the last 2 years (low dose steroids ≤ 5 mg prednisone equivalent allowed).
- Are unlikely to comply with study procedures or are otherwise unsuitable for enrollment.
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Trial Site Locations
Total: 6 locations
1
University of California, Irvine - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
2
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Duke Cancer Institute
Durham, North Carolina, United States, 27705
Actively Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
G
Gail Brown, MD
CONTACT
H
Heather Nottingham, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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