Using CTO1681 to prevent cytokine release syndrome in DLBCL patients receiving CAR T-cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the effectiveness of CTO1681 in preventing or reducing cytokine release syndrome (CRS) in adult patients with diffuse large B-cell lymphoma (DLBCL) who are scheduled to receive CD19-directed CAR T-cell therapy. The study consists of two phases, with the first phase being an open-label, dose escalation safety assessment. Participants will start taking CTO1681 just before their CAR T-cell therapy and continue for 15 days, during which various medical evaluations and sample collections will occur to monitor safety and efficacy. The study aims to gather data on the potential benefits of CTO1681 in mitigating CAR T-cell therapy-related toxicities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 years or older.
2. Undergone leukapheresis and is scheduled to receive protocol-specified CAR T-cell therapy (axicabtagene ciloleucel, lisocabtagene maraleucel, idecabtagene vicleucel, or ciltacabtagene autoleucel) for relapsed or refractory lymphoma or multiple myeloma. All patients must have relapsed or refractory disease to at least one prior line of systemic therapy. Prior CAR T-cell therapy is allowable with approval from the Sponsor and Medical Monitor.
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.
   5. Platelets ≥ 50,000/mm3.
   6. Absolute neutrophil count \> 1000/μL.
   7. Absolute lymphocyte count \> 100/μL.
5. Disease specification must match the indication described in the product label of the planned CAR T-cell product.
6. Eastern Cooperative Oncology Group performance status 0 to 1.
7. Female participants of childbearing potential and all male participants must agree to use Investigator-approved methods of birth control while on study drug and for 30 days thereafter.
8. Patients who are willing to provide written informed consent before the predose procedures, or patients who have a legal representative capable of providing informed consent on their behalf.

Exclusion Criteria:

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. A patient with an ECG abnormality may be enrolled only after approval by the Medical Monitor and Sponsor.
5. Active central nervous system (CNS) lymphoma (history of CNS involvement may be allowable only after approval by the Medical Monitor and Sponsor).
6. Any clinically significant (ie, active) cardiovascular disease, including cerebral vascular accident/stroke (\< 6 months before enrollment), myocardial infarction (\< 6 months before enrollment) or unstable angina, and congestive heart failure ≥ New York Heart Association Classification Class III.
7. Uncontrolled thromboembolic events or recent severe hemorrhage within the last 6 months.
8. Known history of any bleeding disorder.
9. Requirement for ongoing therapeutic doses of anticoagulant therapy, antiplatelet or fibrinolytic agents (low molecular weight heparin prophylaxis is allowed).
10. Baseline systolic blood pressure \<100 mmHg.
11. History of autoimmune disease/ graft versus host disease requiring immunosuppressive therapy within the last 2 years. However, physiologic steroids may be given at a dose of 5 mg or less (prednisone equivalent).
12. Patients who, in the opinion of the Investigator, would be unlikely to comply with study procedures or are otherwise unsuitable for enrollment.
13. Planned prophylactic treatment for CRS or ICANS with corticosteroids or any immunomodulatory or anticytokine therapies (including but not limited to tocilizumab and anakinra).

Where it's running

• University of California, Irvine - Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• Georgia Cancer Center at Augusta University
  Augusta, Georgia, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Duke Cancer Institute
  Durham, North Carolina, United States Recruiting
• University of Pittsburgh Medical Center
  Pittsburgh, Pennsylvania, United States Recruiting
• Fred Hutchinson Cancer Center
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Gail Brown, MD
• Email: gail@tekteam.net
• Phone: 650-868-2182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.