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Prevention study for Cytokine Release Syndrome
Official title Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
ClinicalTrials.gov ID: NCT05905328
What this study is testing
What is CTO1681 10 μg?
CTO1681 10 μg is an investigational medicine, given as an once-daily, being studied as a potential treatment for cytokine release syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older.
- Undergone leukapheresis and is scheduled to receive protocol-specified commercially available CD19-directed CAR T-cell therapy (axicabtagene...
- Met all for CAR T-cell therapy per institutional guidelines.
- Adequate organ function defined as:
- Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min.
You likely can't join if
- Any cytotoxic chemotherapy within 14 days prior to leukapheresis.
- Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia...
- Grade 2 or greater electrolyte imbalance, per CTCAE v5.0:
- Potassium \ 5.5 mmol/L
- Sodium \ 150 mmol/L
- Calcium \ 11.5 mg/dL
See the full eligibility criteria
- Age 18 years or older.
- 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...
- Met all for CAR T-cell therapy per institutional guidelines.
- Adequate organ function defined as:
- Estimated Creatinine Clearance per Cockroft Gault formula ≥ 60 mL/min.
- Serum alanine aminotransferase/aspartate aminotransferase ≤ 2.5 × ULN.
- Total bilirubin ≤ 1.5 × ULN.
- Left ventricular ejection fraction ≥ 40% on echocardiogram or multigated acquisition and no clinically significant pericardial effusion.
- Platelets ≥ 50,000/mm3.
- Absolute neutrophil count \> 1000/μL.
- Absolute lymphocyte count \> 100/μL.
- Documented measurable lymphoma disease adequate to judge by Lugano Criteria.
- Eastern Cooperative Oncology Group performance status 0 to 1.
- 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.
- 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.
- Any cytotoxic chemotherapy within 14 days prior to leukapheresis.
- Clinically significant malabsorption syndromes and swallowing difficulties which are inadequately controlled with medication (eg, odynophagia, dysphagia, gastroesophageal reflux disease) as per Investigator assessment.
- Grade 2 or greater electrolyte imbalance, per CTCAE v5.0:
- Potassium \ 5.5 mmol/L
- Sodium \ 150 mmol/L
- Calcium \ 11.5 mg/dL
- Magnesium \ 1.23 mmol/L
- 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...
- History of clinically significant arrhythmia and/or requiring anticoagulation/antiplatelet treatment at therapeutic dose.
- 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...
- Uncontrolled thromboembolic events or recent severe hemorrhage within the last 6 months.
- Known history of any bleeding disorder.
- Requirement for ongoing therapeutic doses of anticoagulant therapy, antiplatelet or fibrinolytic agents (low molecular weight heparin prophylaxis is allowed).
- Baseline systolic blood pressure \<100 mmHg.
- History of autoimmune disease/ graft versus host disease requiring immunosuppressive therapy within the last 2 years. However, physiologic steroids (prednisone equivalent) may be given at a dose of 5 mg or less.
- Patients who, in the opinion of the Investigator, would be unlikely to comply with study procedures or are otherwise unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Augusta, Georgia, United States
- Boston, Massachusetts, United States
- Durham, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Augusta, Georgia, United States; Boston, Massachusetts, United States; Durham, North Carolina, United States; Pittsburgh, Pennsylvania, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.