Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Eligible age
18+ yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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.
Sponsor: CytoAgents, Inc.
You may qualify if…
- ✓ 1. Age 18 years or older.
- ✓ 2. Undergone leukapheresis and is scheduled to receive protocol-specified commercially available CD19-directed CAR T-cell therapy (axicabtagene ciloleucel or lisocabtagene maraleucel) for DLBCL without corticosteroid prophylaxis for CRS and/or ICANS. Patients eligible for study must have relapsed or refractory DLBCL after at least one prior line of systemic therapy.
- ✓ 3. Met all inclusion criteria for CAR T-cell therapy per institutional guidelines.
- ✓ 4. Adequate organ function defined as:
- ✓ 1. Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min.
- ✓ 2. Serum alanine aminotransferase/aspartate aminotransferase ≤ 2.5 × ULN.
- ✓ 3. Total bilirubin ≤ 1.5 × ULN.
- ✓ 4. Left ventricular ejection fraction ≥ 40% on echocardiogram or multigated acquisition and no clinically significant pericardial effusion.
You may not qualify if…
- ✕ 1. Any cytotoxic chemotherapy within 14 days prior to leukapheresis.
- ✕ 2. Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.
- ✕ 3. Grade 2 or greater electrolyte imbalance, per CTCAE v5.0:
- ✕ 1. Potassium \< 3.0 or \> 5.5 mmol/L
- ✕ 2. Sodium \< 130 or \> 150 mmol/L
- ✕ 3. Calcium \< 8.0 or \> 11.5 mg/dL
- ✕ 4. Magnesium \< 0.5 or \> 1.23 mmol/L
- ✕ 4. Clinically significant ECG abnormality at Screening or Baseline (Day -1), including but not limited to, a confirmed QTcF value \> 470 msec. Patients to be excluded included those with QTcF readings that are borderline or difficult to interpret because of a condition such as bundle branch block, or in those where the end of the T wave is difficult to measure. This also includes any Grade 2 or greater conduction block disorder, atrial, or ventricular arrythmia.
Where it's recruiting
Orange
Augusta
Boston
Durham
Pittsburgh
Seattle
Source: ClinicalTrials.gov · NCT05905328 · last updated 2026-04-17