Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
CTA-2101 (primary)
NCI-2023-09252
Summary
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.
Objectives
The first phase of the study will be an open-label, dose escalation, safety assessment in
a group of patients, and will also collect data to investigate the potential benefit of
CTO1681, initiated prior to CAR T-cell therapy, in preventing or reducing certain
toxicities or side effects associated with CAR T-cell therapy, such as cytokine release
syndrome (CRS).
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.
Participants will provide blood samples at specified points throughout the study. In
addition, urine samples, ECGs, scans, and other medical evaluations will be performed
that are associated with the CAR T-cell therapy and/or necessary to verify study
eligibility. Participants will be monitored for safety and efficacy for 43 days, and then
will have follow-up to continue to monitor for safety and monitor for tumor response for
up to 6 months for phase 1.
Eligibility
- Age 18 years or older.
- Undergone leukapheresis and is scheduled to receive protocol-specified commercially available axicabtagene ciloleucel CD19-directed CAR T-cell therapy 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.
- Met all inclusion criteria 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.
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